ClarusScope 3000N

GUDID B0673000N0

Endoscope, Flexible Fiberoptic

CLARUS MEDICAL, LLC

Flexible fibreoptic neuroscope
Primary Device IDB0673000N0
NIH Device Record Key749a4446-92a2-4ad1-a103-79030fda7b91
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarusScope
Version Model Number3000N
Catalog Number3000N
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
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
HIBCCB0673000N0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


[B0673000N0]

Hydrogen Peroxide;Liquid Chemical;Peracetic Acid;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

Devices Manufactured by CLARUS MEDICAL, LLC

10810004821030 - Clarus Digital Inspection Scope, 1mm x 110cm, High Definition2024-02-28 Clarus Digital Inspection Scope, 1mm x 110cm, High Definition
00810004820012 - Clarus Digital ChannelScope Endoscope, 13.0cm2024-02-27 Clarus Digital ChannelScope Endoscope, 13.0cm
00810004820357 - Clarus Digital NeuroPEN Endoscope, 15.5cm2024-02-27 Clarus Digital NeuroPEN Endoscope, 15.5cm
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 Endoscope2024-02-27 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.