Polyethylene wound contact layer
CONFORMANT 2 WND VL4X4IN CS48 - 5955044
Device Description
A sterile, transparent covering that is permeable to fluids intended to be applied to wounded or diseased tissue to provide protection (e.g., from dirt, microbes) and/or promote healing. It is a thin, clear, hydrophilic membrane made of synthetic polymer (e.g., polyurethane based) without an adhesive. It is applied directly to tissue to protect and/or help heal (e.g., as a synthetic skin) burns, skin-graft donor sites, ulcers, laser resurfacing sites, or other partial-thickness wounds. Its permeability allows the passage of wound exudates without removal; the device may be perforated (e.g., meshed) for increased permeability for highly-exudative wounds. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NAC
Device Name: Dressing, Wound, Hydrophilic
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 878.4018
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 30040565119305
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00040565119304
Package Quantity: 48
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 00040565119304
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A