NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982077769
• Version / Model: 03.311.001
• Catalog Number: 03311001
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-31
• Public Version: 3
• Public Version Date: 2022-04-28
• Public Version Status: Update
• Public Device Record Key: 94142a86-58a8-4c84-b4fe-9490aafe2a88

Device Description

TENSIONER

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32886	Wire holding/twisting forceps	A surgical instrument with specially designed sturdy blades used to grip, tighten and/or twist wires that are being applied to the patient during a surgical intervention. It typically has a scissors-like design with ring handles, is made of high-grade stainless steel and may be self-retaining. It is available in various sizes and the working end can have a variety of jaw designs, e.g., typically short and broad with carbide inserts, but some may be long with side protruding posts around which the loose end of the wire are secured to provide greater grip. The blades/handles are typically strong in profile. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07611819815445	GS1
Secondary	H679033110010	HIBCC
Primary	10886982077769	GS1

Customer Contacts

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