eXofin Precision Pen, 1g

Basic Information

• Brand Name: eXofin Precision Pen, 1g
• Primary DI: 00854137001634
• Version / Model: EP70412
• Catalog Number: EP70412
• Company Name: CHEMENCE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 079163089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-10
• Public Version: 2
• Public Version Date: 2022-02-15
• Public Version Status: Update
• Public Device Record Key: ffd92c3d-61a0-4dc7-b044-b977cb1cffa0

Device Description

eXofin Precision Pen High Viscosity Topical Skin Adhesive

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	878.4010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34164	Skin-approximation adhesive	A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00854137001641	GS1	Inner	12	In Commercial Distribution
Primary	00854137001634	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K212246	000