Clarus Flexible Fiberoptic Endoscope 3000C

GUDID B0673000C0

Endoscope, Flexible Fiberoptic

CLARUS MEDICAL, LLC

Flexible fibreoptic epiduroscope Flexible fibreoptic epiduroscope
Primary Device IDB0673000C0
NIH Device Record Key16aa7c89-2f21-4ebf-bd5f-6a6cf59a18db
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarus Flexible Fiberoptic Endoscope
Version Model Number3000C
Catalog Number3000C
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0673000C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0673000C0]

Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide


[B0673000C0]

Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide


Device Entry Metadata

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

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