Identity
- Trade Name
- Tissue Seal FDA UDI
- Generic Name
- Dermal surgical adhesive/sealant applicator FDA UDI
- Device Name
- Topical Skin Adhesive Flex with Tips FDA UDI
- Model / Reference
- 1051260-P FDA UDI
- Description
- Topical Skin Adhesive Flex with Tips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860000589031 FDA UDI
- 510(k) Number
- K140343 FDA UDI
- FDA Product Code
- MPN FDA UDI
- GMDN Term
- Dermal surgical adhesive/sealant applicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4010 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 — 0.5 Milliliter FDA UDI
Category: Skin-approximation adhesiveDermal surgical adhesive/sealant applicator
Tissue Seal by Tissue Seal L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dermal surgical adhesive/sealant applicator.
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- PremierPro — SVS LLC · Class II
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
- Tissue Seal L.l.c.
Sources (1)
- FDA UDI ae27e61c-c7f6-4530-82d0-ffb4c209a147 37 fields · synced Jun 8, 2026