LEWIN BONE HOLDING CLAMP

Basic Information

• Brand Name: LEWIN BONE HOLDING CLAMP
• Primary DI: 00192896047532
• Version / Model: 1100-426
• Catalog Number: 1100-426
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-14
• Public Version: 2
• Public Version Date: 2019-05-16
• Public Version Status: Update
• Public Device Record Key: 94aa6084-855e-47ee-bbd3-9370fc24f211

Device Description

LEWIN BONE REDUCTION CLAMP

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: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDJ	CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34949	Bone approximation clamp	A hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896047532	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	7	Inch