NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982258724
• Version / Model: 04.231.022S
• Catalog Number: 04231022S
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-21
• Public Version: 4
• Public Version Date: 2024-02-27
• Public Version Status: Update
• Public Device Record Key: fe56ca54-6150-458c-8748-f3ed3d8f1db8

Device Description

5.0MM TI VA POSITIONING PIN STERILE

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDQ	Cerclage, fixation	Orthopedic	888.3010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67083	Orthopaedic fixation plate cerclage pin/eye	A small implantable device designed to facilitate implantation of an orthopaedic fixation plate using cerclage cable or wire, whereby it attaches to the plate and/or underlying bone and provides a hole (eye) through which the cerclage cable is threaded. The pin portion may be one of a variety of designs which may be: 1) threaded into plate hole; 2) seated within a plate hole and inserted into the underlying bone; or 3) inserted into the drive hole of an appropriate screw head. It is used for plate fixation when screws are not an option. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H67904231022S0	HIBCC
Primary	10886982258724	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162124	000