Dispos-a-Bite

Basic Information

• Brand Name: Dispos-a-Bite
• Primary DI: 00615375003916
• Version / Model: 7070
• Company Name: METREX RESEARCH, LLC
• Labeler DUNS: 145963778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: 62264240-57d1-4bd4-b56a-7924180250c2

Device Description

Disposable bite blocks Fits Panorex by Keystone

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
EHA	Aligner, beam, x-ray	Dental	872.1820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16205	Dental x-ray film holder, reusable	A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615375003916	GS1
Unit of Use	00615375006948	GS1

Customer Contacts

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