X-RAY MOUNTS QUICK TEAR (1000/ROLL)

Basic Information

• Brand Name: X-RAY MOUNTS QUICK TEAR (1000/ROLL)
• Primary DI: D77810792881
• Version / Model: 107-9288
• Catalog Number: 107-9288
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2021-02-27
• Public Version: 1
• Public Version Date: 2021-03-08
• Public Version Status: New
• Public Device Record Key: e7beacaf-4ba1-4f30-845d-bbc9c8061f00

Device Description

UNIVERSAL FILM MOUNT (1000/roll) Details: Double window, quick tear; For more information: https://www.scottsdental.com/catalog/product/view/id/30360/s/universal-film-mounts-quick-tear/

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
EGZ	Holder, film, x-ray	Dental	872.1905	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
Unit of Use	D77810792880	HIBCC
Primary	D77810792881	HIBCC

Customer Contacts

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