J&J Instruments

Basic Information

• Brand Name: J&J Instruments
• Primary DI: 00817524022841
• Version / Model: 06-850
• Company Name: J & J INSTRUMENTS INC
• Labeler DUNS: 783328149
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-07
• Public Version: 1
• Public Version Date: 2019-10-15
• Public Version Status: New
• Public Device Record Key: 44dc8817-7615-4e3f-88d8-f767bd0c4488

Device Description

WEDGE SHAPED MILLIMETER GAUGE

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIL	Gauge, Depth, Instrument, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44740	Interproximal dental gauge, reusable	A device intended to be used in dentistry to measure the clearance between adjacent teeth (e.g., in orthodontic treatment during reproximation to relieve pressure points between teeth). The device is typically available in a set of stainless steel graduated gauges, typically with notches on the side to help with identification. Device thickness typically ranges from 0.1 mm to 0.5 mm. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817524022841	GS1