AccessGUDID - DEVICE: 9000 Series Disposable Channel Cleaning Brush (00666416120079)

GUDID

Device Identifier (DI) Information

Brand Name: 9000 Series Disposable Channel Cleaning Brush
Version or Model: 9115
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9115-50
Company Name: Primed Instruments Inc

Primary DI Number: 00666416120079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 254491293 *Terms of Use

Device Description: Disposable Channel Cleaning Micro Brush. HIBC/UPN: M45391153

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:	Yes
Prescription Use (Rx):	Yes
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?
38835	Surgical instrument/endoscope cleaning utensil, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	Accessories, Cleaning Brushes, For Endoscope

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: Store cleaning brushes in original packaging at room temperature in a dry clean location away from direct sunlight. Each dispenser box contains 50 individually packed cleaning brushes.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Minimum Channel Size: 2.0mm
Device Size Text, specify: Tapered Brush Diameter: 3.0-5.0mm
Device Size Text, specify: Overall Length: 115cm

Device Record Status

Public Device Record Key: 370e840e-a1fe-46ab-929c-e6f5bbcc84b1
Public Version Date: June 14, 2023
Public Version Number: 5
DI Record Publish Date: October 23, 2017