Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 30649111150009
• Version / Model: 06-2873
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2018-04-16
• Public Version: 1
• Public Version Date: 2018-05-17
• Public Version Status: New
• Public Device Record Key: 560af18b-d73c-4c68-8377-4bf608144d70

Device Description

SURG SCRUB BRUSH W/NAILSCRB 12

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: 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
GEC	BRUSH, SCRUB, OPERATING-ROOM	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47077	Surgical scrub brush, single-use	A hand-held device used by hospital staff to scrub their hands, fingers, and forearms prior to surgery or other intervention where a high degree of personal hygiene is required; it may also be used to mechanically clean the intact skin or superficial wounds of a patient. This device typically has a synthetic sponge surface and a soft bristle surface; it may also include a separate nail cleaner and/or a disinfecting substance. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30649111150009	GS1
Unit of Use	00649111150008	GS1