Identity
- Trade Name
- MANUKAhd Lite Border 10 x 10 cm FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
- Model / Reference
- MM0032 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060188820147 FDA UDI
- 510(k) Number
- K102659 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MANUKAhd Lite Border 10 x 10 cm by Manukamed Limited Partnership — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K102659 also covers:
- First Honey Manuka Bandages — MANUKAMED LIMITED PARTNERSHIP
- First Honey Manuka Bandages — MANUKAMED LIMITED PARTNERSHIP
- First Honey Manuka Dressings — MANUKAMED LIMITED PARTNERSHIP
- MANUKAhd 10 x 12.5 cm — MANUKAMED LIMITED PARTNERSHIP
- MANUKAhd Lite 10 x 12.5 cm — MANUKAMED LIMITED PARTNERSHIP
- MANUKAhd Lite 5 x 5 cm — MANUKAMED LIMITED PARTNERSHIP
- MANUKAhd Lite 5 x 5 cm — MANUKAMED LIMITED PARTNERSHIP
- MANUKAhd Super Lite 10 x 12.5 cm — MANUKAMED LIMITED PARTNERSHIP
- MANUKAhd Super Lite 5 x 5 cm — MANUKAMED LIMITED PARTNERSHIP
- MANUKAhd SuperLite Rolls — MANUKAMED LIMITED PARTNERSHIP
- ManukaMed Adhesive Dressings — MANUKAMED LIMITED PARTNERSHIP
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
- Manukamed Limited Partnership
Sources (1)
- FDA UDI e57eb59f-7aed-4313-942f-e755d785f8e0 34 fields · synced Jun 6, 2026