Clarus Digital ChannelScope Endoscope, 11.0cm 2233-511

GUDID 00810004820395

Clarus Digital ChannelScope Endoscope, 11.0cm

CLARUS MEDICAL, LLC

Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope Rigid video intracranial/spinal endoscope

• Primary Device ID: 00810004820395
• NIH Device Record Key: 96fac70a-1ce0-46bb-bb73-ac0eb469b94a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarus Digital ChannelScope Endoscope, 11.0cm
• Version Model Number: 2233-511
• Catalog Number: 2233-511
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810004820395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223615

FDA Product Code

• GWG: Endoscope, Neurological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-27
• Device Publish Date: 2024-02-19

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• 00810004820395 - Clarus Digital ChannelScope Endoscope, 11.0cm: 2024-02-27 Clarus Digital ChannelScope Endoscope, 11.0cm
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• 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