UNIVERSAL K-WIRE BENDING IRON

Basic Information

• Brand Name: UNIVERSAL K-WIRE BENDING IRON
• Primary DI: 00192896098442
• Version / Model: 1106-206
• Catalog Number: 1106-206
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-31
• Public Version: 1
• Public Version Date: 2019-08-08
• Public Version Status: New
• Public Device Record Key: 174511a1-26a4-468a-a40e-b11c963bdb72

Device Description

UNIVERSAL K-WIRE BENDING IRON DOUBLE ENDED TIPS

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: Yes
• 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", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HXP	Instrument, Bending Or Contouring	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44795	Manual orthopaedic bender, reusable	A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896098442	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			For .032/.045/.054/.062 Wires
Device Size Text, specify			90 Degree Tip