Clarus Digital Control Module 5190-500

GUDID 00810004821019

Clarus Digital Control Module

CLARUS MEDICAL, LLC

Endoscopic video image processing/light source system
Primary Device ID00810004821019
NIH Device Record Key360c4eb5-404c-48a9-a9f4-56a369648f5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarus Digital Control Module
Version Model Number5190-500
Catalog Number5190-500
Company DUNS010316284
Company NameCLARUS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810004821019 [Direct Marking]
GS110810004821016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-27
Device Publish Date2024-02-19

Devices Manufactured by CLARUS MEDICAL, LLC

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00810004820463 - Light Cable, ACMI-ACMI, 1mm2025-01-07 Light Cable, ACMI-ACMI, 1mm
00810004820760 - Forceps, Cup, Down, 2mm, 19.7cm2025-01-07 Forceps, Cup, Down, 2mm, 19.7cm
00810004820777 - Forceps, Grasping, Down, 2mm, 19.7cm2025-01-07 Forceps, Grasping, Down, 2mm, 19.7cm
00810004820784 - Forceps, Grasping, Down, 2mm, 28.5cm2025-01-07 Forceps, Grasping, Down, 2mm, 28.5cm
00810004820876 - Forceps, Grasping, Down, 3mm, 28.5cm2025-01-07 Forceps, Grasping, Down, 3mm, 28.5cm

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