AccessGUDID - DEVICE: 80000 Series Reusable General and Rigid Cleaning Brush (M453889271)

GUDID

Device Identifier (DI) Information

Brand Name: 80000 Series Reusable General and Rigid Cleaning Brush
Version or Model: 88927
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88927
Company Name: Primed Instruments Inc

Primary DI Number: M453889271
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 254491293 *Terms of Use

Device Description: Baron / Frazier Tube Cleaning Brushes. HIBC/UPN: M453889271

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEC	Brush, Scrub, Operating-Room

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Working Length: 12 Inch
Device Size Text, specify: Brush Diameter: 2.3 mm (7 FR)

Device Record Status

Public Device Record Key: 72d6d068-b03f-4cd3-aeb0-5e90363aff39
Public Version Date: June 20, 2023
Public Version Number: 1
DI Record Publish Date: June 12, 2023