Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 10649111279812
• Version / Model: 12-1065
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-26
• Public Version: 1
• Public Version Date: 2018-12-27
• Public Version Status: New
• Public Device Record Key: 5ed64f44-9dbe-404f-aab3-0e7310826f1a

Device Description

LISTON AMP KNIFE 12"(7" BLADE)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
GDN	KNIFE, AMPUTATION	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35131	Amputation knife	A hand-held manual surgical instrument with a handle and a heavy single-edged or double-edged blade, of various shapes and sizes, used in surgery for the amputation of a limb. It is typically a one-piece instrument 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
Primary	10649111279812	GS1