Identity
- Trade Name
- ACTICOAT FLEX7 2.5CMX60CM CTN OF 5 FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
- Device Name
- Silver coated anti-microbial barrier dressing FDA UDI
- Model / Reference
- 66800545 FDA UDI
- Description
- Silver coated anti-microbial barrier dressing FDA UDI
Identifiers
- Catalog Number
- 66800545, 66800544 FDA UDI
- Primary DI / UDI-DI
- 00040565125275 FDA UDI
- 510(k) Number
- K083113 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 Unsafe FDA UDI
Category: Wound-nonadherent dressing, absorbent, antimicrobial
Acticoat Flex7 2.5cmx60cm Ctn Of 5 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
K083113 also covers:
- ACTICOAT FLEX3 16" X 16" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX3 2" X 2" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX3 4" X 4" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX3 4" X 48" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX3 4" X 8" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX3 8" X 16" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX7 16" X 16" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX7 2" x 2" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX7 4" X 5" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX7 6" X 6" — Smith & Nephew Medical, Ltd.
- ACTICOAT FLEX7 8" X 16" — 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 78005e5f-dda7-4b93-8ab6-9ecd740ecd3b 35 fields · synced Jun 8, 2026