Clarus Digital NeuroPEN Endoscope, 15.5cm 2120-515

GUDID 00810004820357

Clarus Digital NeuroPEN Endoscope, 15.5cm

CLARUS MEDICAL, LLC

Rigid video intracranial/spinal endoscope

• Primary Device ID: 00810004820357
• NIH Device Record Key: 107b2043-a61c-42b5-a2e1-35ba095e4271
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarus Digital NeuroPEN Endoscope, 15.5cm
• Version Model Number: 2120-515
• Catalog Number: 2120-515
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810004820357 [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

Devices Manufactured by CLARUS MEDICAL, LLC

• 10810004821030 - Clarus Digital Inspection Scope, 1mm x 110cm, High Definition: 2024-02-28 Clarus Digital Inspection Scope, 1mm x 110cm, High Definition
• 00810004820012 - Clarus Digital ChannelScope Endoscope, 13.0cm: 2024-02-27 Clarus Digital ChannelScope Endoscope, 13.0cm
• 00810004820357 - Clarus Digital NeuroPEN Endoscope, 15.5cm: 2024-02-27Clarus Digital NeuroPEN Endoscope, 15.5cm
• 00810004820357 - Clarus Digital NeuroPEN Endoscope, 15.5cm: 2024-02-27 Clarus Digital NeuroPEN Endoscope, 15.5cm
• 00810004820395 - Clarus Digital ChannelScope Endoscope, 11.0cm: 2024-02-27 Clarus Digital ChannelScope Endoscope, 11.0cm
• 00810004820494 - Clarus Digital NeuroPEN Endoscope, 19.0cm: 2024-02-27 Clarus Digital NeuroPEN Endoscope, 19.0cm
• 00810004821026 - Clarus Digital ClarusScope Endoscope: 2024-02-27 Clarus Digital ClarusScope Endoscope
• 00810004821019 - Clarus Digital Control Module: 2024-02-27 Clarus Digital Control Module
• 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