eXofin Precision Pen, 1g

FDA UDI

Class II (US FDA UDI)

by Chemence Medical Inc.

Identity

Trade Name: eXofin Precision Pen, 1g FDA UDI
Generic Name: Skin-approximation adhesive FDA UDI
Device Name: eXofin Precision Pen High Viscosity Topical Skin Adhesive FDA UDI
Model / Reference: EP70412 FDA UDI
Description: eXofin Precision Pen High Viscosity Topical Skin Adhesive FDA UDI

Identifiers

Catalog Number: EP70412 FDA UDI
Primary DI / UDI-DI: 00854137001634 FDA UDI
510(k) Number: K212246 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

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

FDA UDI

Category: Skin-approximation adhesive

eXofin Precision Pen, 1g by Chemence Medical Inc. — 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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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 — SOURCEMARK, 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

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Manufacturer

Manufacturer: Chemence Medical Inc.

Sources (1)

FDA UDI ffd92c3d-61a0-4dc7-b044-b977cb1cffa0 36 fields · synced Sep 18, 2026