Flex Tab

Basic Information

• Brand Name: Flex Tab
• Primary DI: 10841396117326
• Version / Model: 004-009
• Company Name: KERR CORPORATION
• Labeler DUNS: 847905890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: 960abffe-6eb0-4133-81d7-8512ba38a732

Device Description

Flexible Clearance Tabs - Assorted 3-Pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFH	PAPER, ARTICULATION	Dental	872.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45240	Interproximal/occlusal dental gauge, single-use	A device intended to be used to directly measure the interproximal (adjacent) and/or occlusal (opposing) clearance of a prepared tooth, typically to ensure sufficient space in the development of a dental restoration. The device may be in the form of a flexible tab (e.g., thermoplastic material) available in a variety of standard thicknesses. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841396117326	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.0 mm, 1.5 mm, and 2.0 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE AT AMBIENT TEMPERATURE