Sklar

Basic Information

• Brand Name: Sklar
• Primary DI: 10649111451645
• Version / Model: 12-1075
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-17
• Public Version: 1
• Public Version Date: 2019-06-25
• Public Version Status: New
• Public Device Record Key: 2e7150ef-8f4a-44df-9652-ce6482072414

Device Description

LANGENBECK FLAP KNIFE 4.75 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
38104	Flap knife	A hand-held manual surgical instrument with a handle and a single-edged, contoured blade of various lengths used during the amputation of a limb to surgically create the flap of skin that will be folded over and sutured or clipped in place to cover the amputation wound and form the end of the stump. 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	10649111451645	GS1