Sklar

Basic Information

• Brand Name: Sklar
• Primary DI: 10649111348587
• Version / Model: 50-3062
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-07
• Public Version: 1
• Public Version Date: 2019-05-15
• Public Version Status: New
• Public Device Record Key: 6644aa05-2e11-47dc-9890-67ae01750693

Device Description

VIRCHOW BRAIN KNIFE 7 3/4 INCHES

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
EMF	KNIFE, SURGICAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45737	Brain knife	A hand-held manual surgical instrument with a handle and an extra long, broad blade used during an autopsy to slice evenly across the entire brain mass of a cadaver to obtain clean cut, cross-sectional, pathological samples. It is typically a one-piece instrument made of high-grade stainless steel; the blade is very broad and thin with a rounded tip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10649111348587	GS1