Identity
- Trade Name
- L-Mesitran Soft 0.5oz FDA UDI
- Generic Name
- Medical honey liquid barrier dressing FDA UDI
- Device Name
- L-Mesitran Soft is wound dressing for the use on wounds. L-Mesitran Soft is a gel that contains: 40% medical grade honey, lanolin, propylene glycol, PEG 4000, and vitamins C and E. FDA UDI
- Model / Reference
- 203.01.US FDA UDI
- Description
- L-Mesitran Soft is wound dressing for the use on wounds. L-Mesitran Soft is a gel that contains: 40% medical grade honey, lanolin, propylene glycol, PEG 4000, and vitamins C and E. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717249680734 FDA UDI
- 510(k) Number
- K150676 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Medical honey liquid barrier dressing 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 15 Gram FDA UDI
Category: Medical honey liquid barrier dressing
L-Mesitran Soft 0.5oz by Theo Manufacturing B.V. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical honey liquid barrier dressing.
- MEDIHONEY® — ACELL, INC. · U
- MediHoney® — ACELL, INC. · U
- Dynarex L-Mesitran Soft — Dynarex Corp. · U
- Dr.Med — Roosin Medical Co., Ltd. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · U
- CVS Health® — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · U
- CVS Health® — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · U
- L-Mesitran Tulle — Theo Manufacturing B.V. · U
Cleared under the same submission
K150676 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
- Theo Manufacturing B.V.
Sources (1)
- FDA UDI 0ada965b-ce7a-480c-983a-42542868f659 35 fields · synced May 30, 2026