Identity
- Trade Name
- PremierPro FDA UDI
- Generic Name
- Dermal surgical adhesive/sealant applicator FDA UDI
- Device Name
- PremierPro exofin® Precision Pen 1.0g (1.0ml) FDA UDI
- Model / Reference
- 3475 FDA UDI
- Description
- PremierPro exofin® Precision Pen 1.0g (1.0ml) FDA UDI
Identifiers
- Catalog Number
- 3475 FDA UDI
- Primary DI / UDI-DI
- 00811220033521 FDA UDI
- 510(k) Number
- K212246 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
Category: Dermal surgical adhesive/sealant applicator
PremierPro by Svs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermal surgical adhesive/sealant applicator.
- ACTABOND™ Topical Skin Adhesive — Bergen Medical Products, Inc. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Tissue Seal — TISSUE SEAL L.L.C. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- PremierPro — SVS LLC · Class II
- PremierPro TSAHigh Viscosity Topical Skin Adhesive w/ Mesh 22cm — SVS LLC · Class II
- PremierPro TSA High Viscosity Topical Skin Adhesive, 0.5ml — SVS LLC · Class II
Cleared under the same submission
K212246 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
- Svs Llc
Sources (1)
- FDA UDI d11c7302-fb2d-4b53-ac36-e9b695df628d 37 fields · synced May 30, 2026