NA

Basic Information

• Brand Name: NA
• Primary DI: 20705034734191
• Version / Model: 04.600.023.10S
• Catalog Number: 0460002310S
• Company Name: SYNTHES (U.S.A.) LP
• Labeler DUNS: 832637081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-12-18
• Public Version: 2
• Public Version Date: 2022-08-04
• Public Version Status: Update
• Public Device Record Key: 5e06c678-470a-4304-8e75-32044f2197c5

Device Description

TI DISTRACTOR PINS-14MM 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: Yes
• PM Exempt: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HXW	BENDER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47870	Orthopaedic fixation implant alignment tool	A surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H9810460002310S0	HIBCC
Primary	20705034734191	GS1
Unit of Use	80705034734193	GS1

Customer Contacts

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