Composi-Tight®

Basic Information

• Brand Name: Composi-Tight®
• Primary DI: 00810038094809
• Version / Model: UNVF-100
• Catalog Number: UNVF-100
• Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.
• Labeler DUNS: 057647005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-15
• Public Version: 1
• Public Version Date: 2020-05-25
• Public Version Status: New
• Public Device Record Key: 07469483-8d77-41b7-a804-bb3ee8bd84ae

Device Description

Universal Forceps, for Rubber Dam Clamp/Sectional Matrix Ring

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJG	Forceps, Rubber Dam Clamp	Dental	872.6300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35851	Rubber dam clamp forceps	A hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810038094809	GS1

Customer Contacts

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