Strata-G™

Basic Information

• Brand Name: Strata-G™
• Primary DI: 10810038090563
• Version / Model: SG600
• Catalog Number: SG600
• Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.
• Labeler DUNS: 057647005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-02-14
• Public Version: 1
• Public Version Date: 2023-02-22
• Public Version Status: New
• Public Device Record Key: 13b4831f-4a7c-42d0-90ef-303b4f81ea90

Device Description

Strata-G™ Wide Prep Ring: 2 per package

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: Yes
• 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
JEP	Retainer, Matrix	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33204	Dental matrix band retainer	A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810038090566	GS1
Primary	10810038090563	GS1

Customer Contacts

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