80000 Series Reusable General and Rigid Cleaning Brush

Basic Information

• Brand Name: 80000 Series Reusable General and Rigid Cleaning Brush
• Primary DI: M45388553S1
• Version / Model: 88553S
• Catalog Number: 88553S
• Company Name: Primed Instruments Inc
• Labeler DUNS: 254491293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2023-06-12
• Public Version: 1
• Public Version Date: 2023-06-20
• Public Version Status: New
• Public Device Record Key: cd8276af-8922-46a8-bca9-495c95fda1da

Device Description

Rigid Channel Stiff Wire Cleaning Brushes (Medium to Large Brushes). HIBC/UPN: M45388553S1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34878	Surgical instrument/endoscope cleaning utensil, reusable	A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M45388553S0	HIBCC
Primary	M45388553S1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Working Length: 24 Inch
Device Size Text, specify			Brush Diameter: 10 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cleaning Brushes should be stored at room temperature in a dry clean area away from direct sunlight. Each bag contains 3 brushes.