Identity
- Trade Name
- URGOCELL AG/SILVER FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
- Device Name
- A non-occlusive semi-permeable absorbent dressing impregnated with Silver Salts derived from Technology Lipido-Colloid (TLC). Composed of 3 layers : - Silver Healing Matrix TLC-Ag made of polyester mesh impregnated with hydrocolloid particles (carboxymethylcellulose), vaseline, cohesion polymers and Silver salts - an absorbent polyurethane foam pad - a protective polyurethane backing FDA UDI
- Model / Reference
- 509346 FDA UDI
- Description
- A non-occlusive semi-permeable absorbent dressing impregnated with Silver Salts derived from Technology Lipido-Colloid (TLC). Composed of 3 layers : - Silver Healing Matrix TLC-Ag made of polyester mesh impregnated with hydrocolloid particles (carboxymethylcellulose), vaseline, cohesion polymers and Silver salts - an absorbent polyurethane foam pad - a protective polyurethane backing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03546890035243 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 Laboratoires Urgo — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Laboratoires Urgo
Sources (1)
- FDA UDI c93a1f8c-2470-4d7a-8644-060ca71990e7 36 fields · synced May 31, 2026