Clarus Inspection Scope, Mini, Short C1-350

GUDID 00810004820562

The Clarus Inspection Scope is a device with a flexible working length intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The device includes a fibreoptic bundle to convey images. This is a reusable device.

CLARUS MEDICAL, LLC

Instrument inspection scope
Primary Device ID00810004820562
NIH Device Record Keyd7cfadd4-c7f5-4f3b-abe2-477d0d956fd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarus Inspection Scope, Mini, Short
Version Model NumberC1-350
Catalog NumberC1-350
Company DUNS010316284
Company NameCLARUS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810004820562 [Direct Marking]
GS110810004820569 [Primary]

FDA Product Code

MNLAccessories, Cleaning Brushes, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-29
Device Publish Date2022-07-21

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

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