Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 10649111376474
• Version / Model: 65-4141
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-25
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 62951a29-eb56-40d5-9c6c-b78a350ec384

Device Description

HARMS TRABECULOTOMY PROBE LF

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
HXB	PROBE	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32761	Trabeculotomy probe	A slender, rod-like, hand-held manual surgical instrument made of flexible metal, with a blunt bulbous tip, used during a trabeculotomy procedure to explore and/or open the drainage angle of the sclera from outside the eye. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10649111376474	GS1