Johnson-Promident

Basic Information

• Brand Name: Johnson-Promident
• Primary DI: 00843471101889
• Version / Model: BT-QA
• Catalog Number: BT-QA
• Company Name: Young Innovations, Inc.
• Labeler DUNS: 004193103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-23
• Public Version: 1
• Public Version Date: 2022-12-01
• Public Version Status: New
• Public Device Record Key: 4afeb76a-b340-4691-b76d-b58a39952b2d

Device Description

BUR TOOL FOR MIDWEST QUIET AIR

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: Yes
• 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
EJL	BUR, DENTAL	Dental	872.3240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65182	Dental power tool endpiece inserter/remover	A noninvasive hand-held manual device designed to facilitate insertion, reinsertion, and/or removal of a dental power tool endpiece (e.g., oscillatory file/rasp, saw, or scalpel) into/from a power tool handpiece; it may in addition be used as a holder within a washer/disinfector. The endpiece and handpiece are not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10843471101886	GS1	INNER PACK	1	In Commercial Distribution
Primary	00843471101889	GS1

Customer Contacts

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