Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 10649111389986
• Version / Model: 22-1242C
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-21
• Public Version: 1
• Public Version Date: 2018-07-23
• Public Version Status: New
• Public Device Record Key: 72dbc1db-11c3-42ec-8aa6-d6bb22e38fe6

Device Description

CENSITRAC READY STEVENS TENOT DEL STR BB 4 1/2

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
LRW	SCISSORS, GENERAL, SURGICAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13490	Ophthalmic tenotomy scissors	A hand-held ophthalmic instrument used to cut and/or divide tendon tissue in the eye during surgery, typically to correct a deformity. It comprises two pivoted blades that usually have finger and thumb ring-handles, and which cut with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10649111389986	GS1