Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 40649111219680
• Version / Model: 96-1060
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-05-06
• Public Version: 3
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 535afbf2-0f23-47dd-91e8-90b9afef80b9

Device Description

STER LLETZ LOOP ELEC 15X8 BX/5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGI	ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)	Obstetrics/Gynecology	884.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	40649111219680	GS1
Unit of Use	06491112196806	GS1