Identity
- Trade Name
- Tissue Seal FDA UDI
- Generic Name
- Skin-approximation adhesive FDA UDI
- Device Name
- Topical Skin Adhesive Blue FDA UDI
- Model / Reference
- TS1050044-FP FDA UDI
- Description
- Topical Skin Adhesive Blue FDA UDI
Identifiers
- Catalog Number
- TS1050044-FP FDA UDI
- Primary DI / UDI-DI
- 00860000589000 FDA UDI
- 510(k) Number
- K111959 FDA UDI
- FDA Product Code
- MPN FDA UDI
- GMDN Term
- Skin-approximation adhesive 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 adhesive
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 Skin-approximation adhesive.
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Cleared under the same submission
K111959 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tissue Seal L.l.c.
Sources (1)
- FDA UDI 88386629-b567-4712-8f71-9bdee8dc625a 38 fields · synced Jun 8, 2026