Compo-Pen™

Basic Information

• Brand Name: Compo-Pen™
• Primary DI: 07540172012973
• Version / Model: 160103
• Catalog Number: 160103
• Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
• Labeler DUNS: 626406016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-17
• Public Version: 3
• Public Version Date: 2022-11-01
• Public Version Status: Update
• Public Device Record Key: bb208780-ec94-4af8-97cb-a5df24847962

Device Description

Dental dispensing gun, hand-held

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16196	Dental material cartridge-plunging applicator, single-component	A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540172012973	GS1

Customer Contacts

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