Totally Rimless

Basic Information

• Brand Name: Totally Rimless
• Primary DI: 00781096316212
• Version / Model: TR 240 Diamante Rhodium
• Catalog Number: TRDIAM0ROD053S16
• Company Name: MCGEE GROUP, INC., THE
• Labeler DUNS: 847029543
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-25
• Public Version: 1
• Public Version Date: 2019-11-04
• Public Version Status: New
• Public Device Record Key: bb44e10c-4b06-4a0d-b67f-5849e1437c91

Device Description

Spectacle Frame, Size 53-16-135

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
HQR	Apparatus, cautery, radiofrequency, ac-powered	Ophthalmic	886.4100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32816	Spectacle frame	An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00781096316212	GS1

Customer Contacts

• Phone: [phone] ext. 3068
• Email: [email protected]