NA

Basic Information

• Brand Name: NA
• Primary DI: 10705034720012
• Version / Model: 03.632.422
• Catalog Number: 03632422
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: c987d401-adae-46d9-992e-273342866fd7

Device Description

2.9MM NAVIGABLE PROBE FOR 4.0MM & 4.2MM SCREWS

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: 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
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15275	Bone awl, reusable	A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07611819588967	GS1
Secondary	H981036324220	HIBCC
Primary	10705034720012	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122211	000