Identity
- Trade Name
- LMP Manuka Fill FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Wound dressing consisting of 100% Manuka Honey in a 1.5 oz tube. FDA UDI
- Model / Reference
- WC05 FDA UDI
- Description
- Wound dressing consisting of 100% Manuka Honey in a 1.5 oz tube. FDA UDI
Identifiers
- Catalog Number
- WC05 FDA UDI
- Primary DI / UDI-DI
- 00851028001094 FDA UDI
- 510(k) Number
- K131796 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-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
Yes
FDA UDI
Over-the-Counter
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 1.5 Fluid Ounce FDA UDI
Category: Wound hydrogel dressing, non-antimicrobial
LMP Manuka Fill by Links Medical Products, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, non-antimicrobial.
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- Hyalo4 Care Clear Hydrogel, 100g — Fidia Farmaceutici · U
- CareOne — Ahold U.S.A., Inc. · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- Simpurity — SAFE N SIMPLE LLC · Class I
Cleared under the same submission
K131796 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Links Medical Products, Inc.
Sources (1)
- FDA UDI 0d8548a5-835d-4e70-bee9-9131edea99b2 38 fields · synced Sep 18, 2026