exofin HVTSA Premier Pro, 1g

Basic Information

• Brand Name: exofin HVTSA Premier Pro, 1g
• Primary DI: 00854137001672
• Version / Model: 3470
• Catalog Number: 3470
• Company Name: CHEMENCE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 079163089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-08
• Public Version: 2
• Public Version Date: 2022-02-15
• Public Version Status: Update
• Public Device Record Key: f7f62b26-8253-4db4-9c31-847fd7dccf6a

Device Description

Premier Pro High Viscosity Tissue Adhesive 1.0g

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	10854137001679	GS1	Inner Pack	10	In Commercial Distribution
Primary	00854137001672	GS1
Package	20854137001676	GS1	Case	60	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K152476	000