Sklar

Basic Information

• Brand Name: Sklar
• Primary DI: 10649111010712
• Version / Model: 55-2011
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-25
• Public Version: 1
• Public Version Date: 2019-11-04
• Public Version Status: New
• Public Device Record Key: 12404bc6-acf0-4002-83dc-f22f9c3c6f15

Device Description

GIERTZ-STILLE RIB CUTTER

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTZ	INSTRUMENT, CUTTING, ORTHOPEDIC	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35317	Rib rongeur	A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed to cut and shorten rib bones, and round the rib stumps, during a surgical intervention. It is typically made of metal with a forceps- or pliers-like design, is and designed to withstand the forces required to bite over tough/hard tissue. It is not intended for endoscopic access. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10649111010712	GS1