NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982073334
• Version / Model: 03.118.004
• Catalog Number: 03118004
• 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: 082cab72-d91e-4a92-882e-f4ed95ade1aa

Device Description

3.5MM COMPRESSION/DISTRACTION POST/FOR LOCKING HOLE

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: 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
HWN	INSTRUMENT, COMPRESSION	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47715	Orthopaedic fixation plate tensioner	A hand-held manual surgical instrument designed to apply tension to an orthopaedic implant (typically a fixation plate) to compress a fracture site prior to final fixation of the implant. It is typically designed with two adjustable legs, one terminating with an anchoring loop that is attached to intact bone and the other terminating with a claw that is attached to the implant which has been fixed to one side of the fracture site; after device placement the fracture is compressed through manual operation of a device mechanism (e.g., turning a central screw). It is typically made of high-grade stainless steel and may be used on simple or compound fractures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07611819503557	GS1
Secondary	H679031180040	HIBCC
Primary	10886982073334	GS1

Customer Contacts

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