Identity
- Trade Name
- Advazorb Sacral FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Absorbent foam sacral dressing with film backing, 17cm x 19cm. Advazorb Sacral is a soft, conforming, low adherent polyurethane foam wound dressing with pink polyurethane film backing and soft silicone contact layer that adheres only to normal healthy skin Advazorb Sacral has high fluid absorbency and retention characteristics. Advazorb Sacral also contributes to a pressure relieving protocol when used in conjunction with pressure relieving devices. FDA UDI
- Model / Reference
- CR4501 FDA UDI
- Description
- Absorbent foam sacral dressing with film backing, 17cm x 19cm. Advazorb Sacral is a soft, conforming, low adherent polyurethane foam wound dressing with pink polyurethane film backing and soft silicone contact layer that adheres only to normal healthy skin Advazorb Sacral has high fluid absorbency and retention characteristics. Advazorb Sacral also contributes to a pressure relieving protocol when used in conjunction with pressure relieving devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031482126 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 22 Centimeter FDA UDILength — 23 Centimeter FDA UDI
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Advazorb Sacral by Brightwake Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, absorbent, non-antimicrobial.
- Suprasorb — Huizhou Foryou Medical Devices Co., Ltd. · Class I
- Proximel Silicone Dressing 5x5 — HARTMANN USA INC. · Class I
- Healqu — HEALQU LLC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- Curity — Cardinalhealth · Class I
- 16PW - Class A Blue Metal Detectable - Poly White — Certified Safety Manufacturing, Inc. · U
- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brightwake Limited
Sources (1)
- FDA UDI 417c8985-6daf-4d6c-ba6d-d5a91f8e6c87 35 fields · synced May 30, 2026