ChannelScope, Long, 10K 2232-002

GUDID 00810004820937

ChannelScope, 10K Pixels, Long, 21.6cm Working Length

CLARUS MEDICAL, LLC

Rigid optical neuroscope, single-use

• Primary Device ID: 00810004820937
• NIH Device Record Key: 9e7cafda-7f6c-41b0-8d71-42f96e5e2ec7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChannelScope, Long, 10K
• Version Model Number: 2232-002
• Catalog Number: 2232-002
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• 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

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
• 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
• 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
• 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	00810004820937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945633

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: 2022-01-05
• Device Publish Date: 2021-12-28

Devices Manufactured by CLARUS MEDICAL, LLC

• 00810004820173 - Forceps, Cup, Down, 2mm, 28.5cm: 2025-01-07 Forceps, Cup, Down, 2mm, 28.5cm
• 00810004820319 - Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down: 2025-01-07 Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down
• 00810004820326 - Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down: 2025-01-07 Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down
• 00810004820463 - Light Cable, ACMI-ACMI, 1mm: 2025-01-07 Light Cable, ACMI-ACMI, 1mm
• 00810004820760 - Forceps, Cup, Down, 2mm, 19.7cm: 2025-01-07 Forceps, Cup, Down, 2mm, 19.7cm
• 00810004820777 - Forceps, Grasping, Down, 2mm, 19.7cm: 2025-01-07 Forceps, Grasping, Down, 2mm, 19.7cm
• 00810004820784 - Forceps, Grasping, Down, 2mm, 28.5cm: 2025-01-07 Forceps, Grasping, Down, 2mm, 28.5cm
• 00810004820876 - Forceps, Grasping, Down, 3mm, 28.5cm: 2025-01-07 Forceps, Grasping, Down, 3mm, 28.5cm