Clarus Digital Inspection Scope, 1.9mm OD CD2-1100

GUDID 00810004820005

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 an image sensor chip to convey images. This is a reusable device.

CLARUS MEDICAL, LLC

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• Primary Device ID: 00810004820005
• NIH Device Record Key: 31f3489f-baee-4d33-a1ce-3786592b4dee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarus Digital Inspection Scope, 1.9mm OD
• Version Model Number: CD2-1100
• Catalog Number: CD2-1100
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810004820005 [Direct Marking]
GS1	10810004820002 [Primary]

FDA Product Code

• MNL: Accessories, Cleaning Brushes, For Endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-29
• Device Publish Date: 2022-07-21

Devices Manufactured by CLARUS MEDICAL, LLC

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• 00810004820005 - Clarus Digital Inspection Scope, 1.9mm OD: 2022-07-29The 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 an image sensor chip to convey images. This is a reusable device.
• 00810004820005 - Clarus Digital Inspection Scope, 1.9mm OD: 2022-07-29 The Clarus Inspection Scope is a device with a flexible working length intended for the visual examination of the lumen of an in