Identity
- Trade Name
- ALLEVYN AG NON ADHESIVE 8X8" CTN10 FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
- Device Name
- Non-Adhesive antimicrobial hydrocellular dressing FDA UDI
- Model / Reference
- 66020981 FDA UDI
- Description
- Non-Adhesive antimicrobial hydrocellular dressing FDA UDI
Identifiers
- Catalog Number
- 66020981 FDA UDI
- Primary DI / UDI-DI
- 05000223460013 FDA UDI
- 510(k) Number
- K063835 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
Classification
- Device Class
- U 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Wound-nonadherent dressing, absorbent, antimicrobial
Allevyn Ag Non Adhesive 8x8" Ctn10 by Smith & Nephew Medical, Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, absorbent, antimicrobial.
- Suprasorb P Sensitive Ag — L&R USA INC. · U
- Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLC · U
- DeRoyal — DEROYAL INDUSTRIES, INC. · U
- URGOCELL AG/SILVER — LABORATOIRES URGO · U
- Kendall — Cardinalhealth · U
- Exchange Select — Aafes · U
- Walgreens — WALGREEN CO. · U
- DeRoyal — DEROYAL INDUSTRIES, INC. · U
Cleared under the same submission
K063835 also covers:
- ALLEVYN AG ADHESIVE 7X7" CTN10 — Smith & Nephew Medical, Ltd.
- ALLEVYN AG GENTLE BORDER 10 X 10 CM — Smith & Nephew Medical, Ltd.
- ALLEVYN AG GENTLE BORDER 7.5X7.5CM — Smith & Nephew Medical, Ltd.
- ALLEVYN AG GENTLE BRDER 12.5 X 12.5 CM — Smith & Nephew Medical, Ltd.
- ALLEVYN AG GENTLE BRDER 17.5X17.5CM — Smith & Nephew Medical, Ltd.
- ALLEVYN AG GNTL BRDER 17.5X17.5CM US/CN — Smith & Nephew Medical, Ltd.
- ALLEVYN AG HEEL INTERNATIONAL — Smith & Nephew Medical, Ltd.
- ALLEVYN AG NON ADHESIVE 2X2" CTN10 — Smith & Nephew Medical, Ltd.
- ALLEVYN AG NON ADHESIVE 4X4" CTN10 — Smith & Nephew Medical, Ltd.
- ALLEVYN AG NON ADHESIVE 6X6" CTN10 — Smith & Nephew Medical, Ltd.
- ALLEVYN AG SACRUM LARGE CTN10 — Smith & Nephew Medical, Ltd.
- ALLEVYN Ag Adhesive 3in x 3in — Smith & Nephew Medical, Ltd.
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 U | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI 300b78df-ba5d-450c-abc2-53154928c2c4 35 fields · synced Jun 1, 2026