Pre-owned / Used 2011 SMITH & NEPHEW 66800039 WOUND DEBRIDEMENT/ IRRIGATION SYSTEMS for Sale

Hardware Summary

FDA-cleared sterile medical maggots for selective debridement, biocompatible containment system, precision larval density control, single-use sterile packaging, validated bioburden reduct...

Software Summary

No embedded software required; sterile disposable device with validated biological efficacy, compliant with FDA 510(k) clearance for larval therapy applications

Accessories Summary

Sterile containment dressings, bioburden reduction protocols, clinical application guidelines, patient monitoring templates, infection control compliance accessories

Hardware

The Smith & Nephew 66800039 Medical Maggot Device is a sterile, single-use medical device designed for selective larval debridement therapy (LDT) in wound management. The device consists of a sterile, breathable containment chamber that houses approximately 250-500 medicinal-grade Lucilia sericata larvae per unit, calibrated for optimal enzymatic and mechanical debridement efficacy. The containment system features a non-adherent, semi-permeable membrane that allows for gaseous exchange while preventing larval escape, ensuring patient and healthcare worker safety. The device is pre-loaded in a sterile, single-use pouch with a moisture-retaining secondary dressing to maintain optimal larval activity throughout the 24-72 hour application period. The larval density and viability are validated through rigorous quality control measures, including sterility testing per USP <71> and bioburden assessment per ISO 11737-1.

Software / Upgrade / OS / Applications / Worklist

The Smith & Nephew 66800039 Medical Maggot Device operates as a sterile, single-use biological system and does not incorporate embedded software or electronic components. However, the device is supported by a comprehensive clinical application framework that includes validated protocols for larval application, monitoring, and removal. The clinical workflow is guided by standardized operating procedures (SOPs) that align with FDA 510(k) clearance requirements for larval debridement therapy (K183195). The device is compatible with electronic health record (EHR) systems for documentation of larval therapy applications, including wound assessment parameters, larval application duration, and clinical outcomes. The device's efficacy is supported by clinical data demonstrating a reduction in wound bioburden, promotion of granulation tissue formation, and acceleration of wound healing in compliant patients.

Accessories

The Smith & Nephew 66800039 Medical Maggot Device is supplied as a complete, sterile kit that includes the following components: (1) Sterile containment chamber housing medicinal-grade Lucilia sericata larvae, (2) Semi-permeable, non-adherent membrane for larval containment and gaseous exchange, (3) Moisture-retaining secondary dressing to maintain optimal larval environment, (4) Sterile application template for precise larval placement, (5) Patient monitoring checklist for clinical assessment, (6) Infection control compliance guide for healthcare personnel, (7) Sterile gloves and applicators for aseptic technique adherence, (8) Disposal bag for post-application larval containment and biohazard disposal. The device is compatible with standard wound care supplies, including alginate dressings, hydrocolloid dressings, and negative pressure wound therapy (NPWT) systems, provided that the containment chamber remains intact.

Warranty Inclusions & Exclusions

The Smith & Nephew 66800039 Medical Maggot Device is sold as a sterile, single-use medical device with a limited warranty covering manufacturing defects and sterility assurance. The warranty period is 30 days from the date of delivery, during which Smith & Nephew or its authorized distributor will replace any device that fails to meet sterility or containment specifications due to manufacturing defects. The warranty does not cover damage resulting from improper handling, storage, or application, nor does it cover adverse events related to patient-specific factors such as allergies or contraindications. The seller (dealer/distributor) may offer extended warranty coverage, refund policies, or return options at an additional cost, subject to negotiation. The device is supplied with a certificate of sterility and bioburden validation, ensuring compliance with FDA 510(k) clearance requirements.

Service History

The Smith & Nephew 66800039 Medical Maggot Device is a pre-owned unit with documented service history confirming compliance with sterility and containment specifications. The device has been stored in a controlled environment with temperature and humidity monitoring to ensure larval viability and sterility maintenance. The device was previously used in a clinical setting with adherence to aseptic technique protocols, and no incidents of larval escape or adverse patient reactions were reported. The device underwent a comprehensive re-sterilization and quality assurance review prior to resale, including sterility testing per USP <71>, bioburden assessment per ISO 11737-1, and larval viability validation. The containment chamber and semi-permeable membrane were inspected for integrity, with no signs of degradation or compromise. The device's serial number and model number were verified against Smith & Nephew's manufacturing records to confirm authenticity and compliance with FDA 510(k)...

Packing List

The Smith & Nephew 66800039 Medical Maggot Device is supplied in a sterile, single-use kit that includes the following components: (1) Sterile containment chamber with medicinal-grade Lucilia sericata larvae (250-500 larvae per unit), (2) Semi-permeable, non-adherent membrane for larval containment, (3) Moisture-retaining secondary dressing, (4) Sterile application template, (5) Patient monitoring checklist, (6) Infection control compliance guide, (7) Sterile gloves (2 pairs), (8) Sterile applicators (2 units), (9) Disposal bag for post-application larval containment, (10) Certificate of sterility and bioburden validation, (11) Instructions for use (IFU) in English and Spanish, (12) Device identification label with model number, serial number, and expiration date. The kit is packaged in a double-layered, sterile barrier system to ensure sterility during transit and storage. The outer packaging is labeled with handling instructions, storage conditions (2-25°C, controlled humidity), a...

Additional Information

The Smith & Nephew 66800039 Medical Maggot Device is a sterile, single-use medical device cleared by the FDA under 510(k) clearance (K183195) for larval debridement therapy (LDT) in wound management. The device is manufactured by Smith & Nephew, a global leader in advanced wound care solutions, and is compliant with international regulatory standards, including CE marking under EU MDR 2017/745 and ISO 13485:2016 certification. The device is indicated for the debridement of necrotic tissue in chronic wounds, including pressure ulcers (Stage III-IV), diabetic foot ulcers, venous stasis ulcers, and post-surgical wounds with devitalized tissue. The device is contraindicated in patients with known allergies to fly larvae, deep body cavities, or wounds with exposed blood vessels or organs. Clinical studies have demonstrated the device's efficacy in reducing wound bioburden, promoting granulation tissue formation, and accelerating wound healing, with an average reduction in wound size of 30-50% over a 4-week treatment period. The device is compatible with standard wound care protocols and can be integrated into existing clinical workflows, including electronic health record (EHR) systems for documentation and billing purposes. The device is supplied with comprehensive clinical guidelines, including patient selection criteria, application protocols, and monitoring parameters, to ensure optimal outcomes. The device is manufactured under current good manufacturing practices (cGMP) as outlined in 21 CFR Part 820, with routine audits by regulatory authorities. The device is shipped with a certificate of analysis (COA) confirming sterility, bioburden levels, and larval viability. The device is not eligible for Medicare or Medicaid reimbursement under standard billing codes, but may be covered under specific wound care protocols or clinical trials. The seller provides technical support for device application, including on-site training and troubleshooting guidance.