CERTAIN®

Basic Information

• Brand Name: CERTAIN®
• Primary DI: 00844868007999
• Version / Model: ISRT10
• Company Name: BIOMET 3I, LLC
• Labeler DUNS: 186127825
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-18
• Public Version: 4
• Public Version Date: 2022-03-10
• Public Version Status: Update
• Public Device Record Key: 298d2e98-1f44-45bd-a8f8-196bedd4e81f
• Distribution End Date: 2016-10-28

Device Description

CERTAIN® SCREW REMOVAL TOOL KIT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
NDP	ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45319	Dental implant extractor	A manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844868007999	GS1

Customer Contacts

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