Clarus Digital ClarusScope Endoscope 2100-500

GUDID 00810004821026

Clarus Digital ClarusScope Endoscope

CLARUS MEDICAL, LLC

Rigid video intracranial/spinal endoscope
Primary Device ID00810004821026
NIH Device Record Keya2ea5fb5-20bd-462d-b3ef-439ea1a3a609
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarus Digital ClarusScope Endoscope
Version Model Number2100-500
Catalog Number2100-500
Company DUNS010316284
Company NameCLARUS MEDICAL, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
GS100810004821026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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00810004820395 - Clarus Digital ChannelScope Endoscope, 11.0cm2024-02-27 Clarus Digital ChannelScope Endoscope, 11.0cm
00810004820494 - Clarus Digital NeuroPEN Endoscope, 19.0cm2024-02-27 Clarus Digital NeuroPEN Endoscope, 19.0cm
00810004821026 - Clarus Digital ClarusScope Endoscope2024-02-27Clarus Digital ClarusScope Endoscope
00810004821026 - Clarus Digital ClarusScope Endoscope2024-02-27 Clarus Digital ClarusScope Endoscope
00810004821019 - Clarus Digital Control Module2024-02-27 Clarus Digital Control Module
00810004820005 - Clarus Digital Inspection Scope, 1.9mm OD2022-07-29 The Clarus Inspection Scope is a device with a flexible working length intended for the visual examination of the lumen of an in

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