AccessGUDID - DEVICE: Clarus Digital Inspection Scope, 1mm x 110cm (10810004820644)

GUDID

Device Identifier (DI) Information

Brand Name: Clarus Digital Inspection Scope, 1mm x 110cm
Version or Model: CB1-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CB1-110
Company Name: CLARUS MEDICAL, LLC

Primary DI Number: 10810004820644
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010316284 *Terms of Use

Device Description: The Clarus Inspection Scope is a device with a flexible working length intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The device includes an image sensor chip to convey images. This is a reusable device.

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":	No
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?
62721	Instrument inspection scope	An endoscope-like device with a flexible working length intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The device includes a fibreoptic bundle or charge-coupled device (CCD) to convey images. This is a reusable 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
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 253f1081-bf77-413b-b6eb-bab779b6ba03
Public Version Date: July 29, 2022
Public Version Number: 1
DI Record Publish Date: July 21, 2022