K-WIRE PIN DRIVER VISE

Basic Information

• Brand Name: K-WIRE PIN DRIVER VISE
• Primary DI: 00192896101098
• Version / Model: 1103-180T
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-16
• Public Version: 1
• Public Version Date: 2020-03-24
• Public Version Status: New
• Public Device Record Key: 2d59d7cf-3da5-4ff9-9103-92172400b54a

Device Description

TITANIUM K-WIRE PIN DRIVER VISE

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
GFC	DRIVER, SURGICAL, PIN	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35436	Manual wire driver	A hand-held manual surgical instrument (drill-like) designed to drive orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different thickness that are pointed for self-drilling) into fractured/deformed bones for their restoration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896101098	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6.375	Inch
Device Size Text, specify			Up to 1.5 Millimeter