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Gemcore360

FDA UDI

Class U (US FDA UDI)

by Advanced Medical Solutions Limited

Identity

Trade Name
GEMCORE360 FDA UDI
Generic Name
Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
Device Name
PHMB Foam Non-Adhesive (Gamma) FDA UDI
Model / Reference
PHMB Foam Antimicrobial Non-Border, Non-Adhesive FDA UDI
Description
PHMB Foam Non-Adhesive (Gamma) FDA UDI

Identifiers

Catalog Number
AM-WC-PHMBFNB44 FDA UDI
Primary DI / UDI-DI
10610888000329 FDA UDI
510(k) Number
K181197 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Exudate-absorbent dressing, non-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

Gemcore360 by Advanced Medical Solutions Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K181197 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Medical Solutions Limited

Sources (1)

  • FDA UDI e79b2661-9a28-4d45-a771-466df286f049 36 fields · synced Jun 8, 2026