Identity
- Trade Name
- FloraSeal FDA UDI
- Generic Name
- Surgical skin microbial sealant FDA UDI
- Device Name
- FloraSeal Microbial Sealant FDA UDI
- Model / Reference
- FS250D FDA UDI
- Description
- FloraSeal Microbial Sealant FDA UDI
Identifiers
- Catalog Number
- FS-250D FDA UDI
- Primary DI / UDI-DI
- M495FS250D1 FDA UDI
- 510(k) Number
- K083354 FDA UDI
- FDA Product Code
- NZP FDA UDI
- GMDN Term
- Surgical skin microbial sealant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
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
Dimensions & Sizes
- Size
- Total Volume — 2.5 Milliliter FDA UDI
Category: Surgical skin microbial sealant
FloraSeal by Adhezion Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical skin microbial sealant.
- Halyard — Avanos Medical, Inc. · Class II
- INTEGUSEAL — Advanced Medical Solutions (Plymouth), Ltd. · Class II
- INTEGUSEAL — Advanced Medical Solutions (Plymouth), Ltd. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- FloraSeal Mini — Adhezion Biomedical, LLC · Class II
Cleared under the same submission
K083354 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 II | Pending data |
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Manufacturer
- Manufacturer
- Adhezion Biomedical, LLC
Sources (1)
- FDA UDI 243993ac-0edf-4ecc-87dd-817e6842fc70 38 fields · synced Jun 1, 2026