LCP

Basic Information

• Brand Name: LCP
• Primary DI: 10886982187437
• Version / Model: 311.449
• Catalog Number: 311449
• 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: 4
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: a3e10030-b69a-4853-b850-0893962cf7a8

Device Description

PUSH-PULL REDUCTION DEVICE FOR 4.5MM LCP® PLATES

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
HTD	FORCEPS	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47904	Orthopaedic bone-reduction tool	A hand-held manual surgical instrument that is fed down the intramedullary canal of a long bone (e.g., the femur) to help reposition a fracture where the two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. It is typically a short cylindrical device with a protruding pointed tip (straight or angled) and which is secured to the distal end of a long, thin, flexible rod/shaft having a handle at the proximal end. It is pressed down the intramedullary canal to the fracture site and the surgeon manipulates the alignment, reducing the bone fragments under image-intensifier control. It is made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07611819915282	GS1
Secondary	H6793114490	HIBCC
Primary	10886982187437	GS1

Customer Contacts

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