Single Patient CERTAIN® Countersink Drill

Basic Information

• Brand Name: Single Patient CERTAIN® Countersink Drill
• Primary DI: 00844868052227
• Version / Model: SPICD100
• Company Name: ZimVie US Corp LLC
• Labeler DUNS: 119287313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-18
• Public Version: 2
• Public Version Date: 2026-01-15
• Public Version Status: Update
• Public Device Record Key: 9ad881e1-7242-48fb-9506-b0364643d102

Device Description

Single Patient CERTAIN® Countersink Drill, 4mmD

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
45697	Fixture/appliance dental drill bit, single-use	A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844868052227	GS1

Customer Contacts

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