Small Cannulated Countersink AO 125mm

Basic Information

• Brand Name: Small Cannulated Countersink AO 125mm
• Primary DI: 00810074306232
• Version / Model: 320-0010
• Catalog Number: 320-0010
• Company Name: Osteocentric Technologies, Inc.
• Labeler DUNS: 089645059
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-06
• Public Version: 2
• Public Version Date: 2025-01-15
• Public Version Status: Update
• Public Device Record Key: f92d39d4-644e-4a46-bbe1-11423c95a504

Device Description

Small Cannulated Countersink AO 125mm

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: No
• 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
HWW	Countersink	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16462	Surgical countersink, reusable	A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810074306232	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170021	000

Device Sizes

Type	Value	Unit	Text
Length	125	Millimeter