Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Skin-approximation adhesive FDA UDI
- Device Name
- SurgiSeal Stylus topical skin adhesive FDA UDI
- Model / Reference
- 5703554 FDA UDI
- Description
- SurgiSeal Stylus topical skin adhesive FDA UDI
Identifiers
- Catalog Number
- 5703554 FDA UDI
- Primary DI / UDI-DI
- 10304040178857 FDA UDI
- 510(k) Number
- K130474 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
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
No
FDA UDI
Category: Skin-approximation adhesive
Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin-approximation adhesive.
- Tissue Seal — TISSUE SEAL L.L.C. · Class II
- LiquiBand Octyl Mini — Advanced Medical Solutions (Plymouth), Ltd. · Class II
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- LiquiBand Flow Control — Advanced Medical Solutions (Plymouth), Ltd. · Class II
- Tissue Seal — TISSUE SEAL L.L.C. · Class II
- Topical Skin Adhesive — Covidien LP · Class II
- exofin SC — CHEMENCE MEDICAL INC. · Class II
- Exofin — SOURCEMARK, LLC. · Class II
Cleared under the same submission
K130474 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
- Henry Schein, Inc.
Sources (1)
- FDA UDI a09a497b-daf6-433f-bc50-de626302e60d 35 fields · synced Jun 8, 2026