JEDMED

Basic Information

• Brand Name: JEDMED
• Primary DI: M633680501B4
• Version / Model: 68-0501 B
• Catalog Number: 68-0501 B
• Company Name: JEDMED INSTRUMENT COMPANY
• Labeler DUNS: 092987189
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2023-02-03
• Public Version: 1
• Public Version Date: 2023-02-13
• Public Version Status: New
• Public Device Record Key: d52916af-10a9-4fae-a2d9-f7244749bc77

Device Description

MOUTH MIRRORS MEGA HD SIZE 5 BX/12

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: Yes
• Has Manufacturing Date: No
• 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
EAX	Mirror, Mouth	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31776	Dental mirror, reusable	A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. 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	M633680501	HIBCC
Primary	M633680501B4	HIBCC