Identity
- Trade Name
- Mepore® Film FDA UDI
- Generic Name
- Wound hydrogel dressing, antimicrobial FDA UDI
- Device Name
- Normlgel Ag 45g FDA UDI
- Model / Reference
- 350450 FDA UDI
- Description
- Normlgel Ag 45g FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07332551958503 FDA UDI
- 510(k) Number
- K110458 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound hydrogel dressing, 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound hydrogel dressing, antimicrobial
Mepore® Film by Mölnlycke Health Care AB — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, antimicrobial.
- Pure&Clean — Pure & Clean, LLC · U
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- BlastX™ — Next Science LLC · U
- Silver-sept Silver Antimicrobial Skin and Wound Gel — Anacapa Technologies, Inc. · U
- ProCure — Twin Med, LLC · U
- Armor Gel — Abl Medical, LLC · U
- L-Mesitran Hydro — Theo Manufacturing B.V. · U
- Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca — ARGENTUM MEDICAL, LLC · U
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
- Mölnlycke Health Care AB
Sources (1)
- FDA UDI 21f174a1-37b2-43b3-8688-00f154323a90 36 fields · synced May 30, 2026