AccessGUDID - DEVICE: Clarus Digital Control Module (10810004821016)

GUDID

Device Identifier (DI) Information

Brand Name: Clarus Digital Control Module
Version or Model: 5190-500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5190-500
Company Name: CLARUS MEDICAL, LLC

Primary DI Number: 10810004821016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010316284 *Terms of Use

Device Description: Clarus Digital Control Module

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):	Yes
Over the Counter (OTC):	No
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?
34540	Endoscopic video image processing/light source system	A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWG	Endoscope, Neurological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223615	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 360c4eb5-404c-48a9-a9f4-56a369648f5d
Public Version Date: February 27, 2024
Public Version Number: 1
DI Record Publish Date: February 19, 2024