Identity
- Trade Name
- UrgoCell Ag/ Silver FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
- Device Name
- A non-adhesive, non-occlusive, antimicrobial absorbent dressing composed of 1) a polyester mesh impregnated with a matrix comprising of hydrocolloid particle (carboxymethylcellulose), cohesiopolymers, petrolatum and silver sulfate, 2) a non-sensitizing, super absorbent polyurethane foam pad, 3) a protective, semi-permeable polyurethane foam backing. FDA UDI
- Model / Reference
- 509346 FDA UDI
- Description
- A non-adhesive, non-occlusive, antimicrobial absorbent dressing composed of 1) a polyester mesh impregnated with a matrix comprising of hydrocolloid particle (carboxymethylcellulose), cohesiopolymers, petrolatum and silver sulfate, 2) a non-sensitizing, super absorbent polyurethane foam pad, 3) a protective, semi-permeable polyurethane foam backing. FDA UDI
Identifiers
- Catalog Number
- 509346 FDA UDI
- Primary DI / UDI-DI
- 00190769093464 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
Yes
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
Category: Wound-nonadherent dressing, absorbent, antimicrobial
UrgoCell Ag/ Silver by Urgo Medical North America, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wound-nonadherent dressing, absorbent, antimicrobial.
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- URGOCELL AG/SILVER — LABORATOIRES URGO · U
- Kendall — Cardinalhealth · U
- Exchange Select — Aafes · U
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
- Urgo Medical North America, LLC
Sources (1)
- FDA UDI 25e9fae1-c403-4bba-863f-19ea1dcb970f 37 fields · synced Jun 9, 2026