SafeClean ® Hand/Nail Brushes

Basic Information

• Brand Name: SafeClean ® Hand/Nail Brushes
• Primary DI: 00840113209811
• Version / Model: 244001BBG
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-28
• Public Version: 1
• Public Version Date: 2021-04-05
• Public Version Status: New
• Public Device Record Key: 5b3d94e7-b771-47c2-b5c5-a89534dd79d0

Device Description

Intended to remove surgical residue from surgical instruments and endoscopic devices after surgical procedures

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: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNL	ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE	Gastroenterology, Urology	876.1500	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
Package	10840113209818	GS1		2	In Commercial Distribution
Primary	00840113209811	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]