ALLEVYN Gentle Border Sacrum
Silicone gel adhesive hydrocellular sacrum dressing
ALLEVYN Gentle Border Sacrum - 66020413
Device Description
A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.
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: NAD
Device Name: Dressing, Wound, Occlusive
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: 878.4020
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 05000223483081
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223476120
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton
Device Id: 05000223476120
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
Device Id: 05000223476137
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223476120
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: carton 66800898
Device Id: 05000223476144
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223476137
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: case 66800898
Device Id: 05000223483098
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223483081
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: case 66020413