NITINOL K WIRE PIN

Basic Information

• Brand Name: NITINOL K WIRE PIN
• Primary DI: B0991106719B0
• Version / Model: 1106-719B
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 816e9333-3eda-459a-81ae-8afbf101ad2c
• Distribution End Date: 2018-09-22

Device Description

NITINOL K WIRE PIN ROUND END WITH ROUND END

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTY	Pin, Fixation, Smooth	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46865	Clavicle fixation rod	A small-diameter implantable rod intended to be used for the fixation of a bone fracture or bone grafts, an osteotomy, or an arthrodesis, in the presence of additional immobilization, typically to treat midshaft fractures, nonunions, and malunions of the clavicle bone. Commonly referred to as a pin, it is typically partially-threaded and may be fitted with a securing nut and is capable of being fitted into the intramedullary canal of the clavicle through a small incision. It is typically made of surgical stainless steel. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B0991106719B0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100736	000

Device Sizes

Type	Value	Unit	Text
Length	500	Millimeter
Width	1.4	Millimeter