Identity
- Trade Name
- SiliGentle AG Silver Silicone Foam Dressing FDA UDI
- Generic Name
- Cavity-wound management dressing, antimicrobial FDA UDI
- Device Name
- SiliGentle AG Silver Silicone Foam Dressing, Non-Bordered, 6" x 6" (15cm x 15cm), High Absorbency, For Wound Stages 2,3,4 FDA UDI
- Model / Reference
- 3083 FDA UDI
- Description
- SiliGentle AG Silver Silicone Foam Dressing, Non-Bordered, 6" x 6" (15cm x 15cm), High Absorbency, For Wound Stages 2,3,4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784308319 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Cavity-wound management dressing, 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cavity-wound management dressing, antimicrobial
SiliGentle AG Silver Silicone Foam Dressing by Dynarex Corp. — 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
- Dynarex Corp.
Sources (1)
- FDA UDI b0f69455-2176-4c4d-b689-17e6f11fc4f0 33 fields · synced May 31, 2026