Identity
- Trade Name
- Resta Silver Gel Bellows Bottle FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds. FDA UDI
- Model / Reference
- 08596 FDA UDI
- Description
- Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds. FDA UDI
Identifiers
- Catalog Number
- 08596 FDA UDI
- Primary DI / UDI-DI
- 00190769085964 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 1 Fluid Ounce FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Resta Silver Gel Bellows Bottle 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 Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.
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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
- Urgo Medical North America, LLC
Sources (1)
- FDA UDI 772e762e-1921-4e32-b601-ab79ef0b70bf 37 fields · synced Jun 9, 2026