PremierPro

FDA UDI

Class II (US FDA UDI)

by Svs Llc

Identity

Trade Name: PremierPro FDA UDI
Generic Name: Dermal surgical adhesive/sealant applicator FDA UDI
Device Name: EXOFINFUSION® Skin Closure System, 30cm FDA UDI
Model / Reference: 3474 FDA UDI
Description: EXOFINFUSION® Skin Closure System, 30cm FDA UDI

Identifiers

Catalog Number: 3474 FDA UDI
Primary DI / UDI-DI: 00811220032876 FDA UDI
FDA Product Code: OMD FDA UDI
GMDN Term: Dermal surgical adhesive/sealant applicator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4011 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dermal surgical adhesive/sealant applicator

PremierPro by Svs Llc — 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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Tissue Seal — TISSUE SEAL L.L.C. · Class II
Henry Schein — HENRY SCHEIN, INC. · 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
PremierPro TSA High Viscosity Topical Skin Adhesive, 1.0ml — 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: Svs Llc

Sources (1)

FDA UDI eea068f4-ed85-41b0-8d4d-97fe11a6d645 36 fields · synced May 30, 2026