BEVEL

Basic Information

• Brand Name: BEVEL
• Primary DI: 00810109932702
• Version / Model: 6543GTWR
• Company Name: Incite International Inc
• Labeler DUNS: 113911866
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-01
• Public Version: 1
• Public Version Date: 2022-08-09
• Public Version Status: New
• Public Device Record Key: ffa4300f-34dc-4ec2-9165-58f43ce3f8cf

Device Description

PETRA - GTWR - Granite/Warm Red - 53 * 16 - 136

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
HQZ	Frame, Spectacle	Ophthalmic	886.5842	1

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
Secondary	G1316543GTWR0	HIBCC
Primary	00810109932702	GS1

Customer Contacts

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