Identity
- Trade Name
- GEMCORE360 FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- Silver Gel Tube 45g, flowerpot FDA UDI
- Model / Reference
- Silver Hydrogel FDA UDI
- Description
- Silver Gel Tube 45g, flowerpot FDA UDI
Identifiers
- Catalog Number
- AM-WC-SHGEL45 FDA UDI
- Primary DI / UDI-DI
- 10610888002071 FDA UDI
- 510(k) Number
- K110458 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
- Not 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
MR Unsafe FDA UDI
Gemcore360 by Advanced Medical Solutions Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K110458 also covers:
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
- Advanced Medical Solutions Limited
Sources (1)
- FDA UDI 86ff5283-6148-4d2d-bd36-08c662cde2a3 36 fields · synced Jun 1, 2026