ShuntPen Cannula 2120C

GUDID B0672120C1

ShuntPen Cannula, to be used with Clarus 3000N Flexible Fiberoptic Endoscope.

CLARUS MEDICAL, LLC

Neuroscopic shunt placement kit

• Primary Device ID: B0672120C1
• NIH Device Record Key: 6a3a5f09-0a83-4ec6-9ef9-00ff2421fe99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShuntPen Cannula
• Version Model Number: 2120C
• Catalog Number: 2120C
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• Device Count: 5
• 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

Customer Support Contacts

• 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
HIBCC	B0672120C0 [Unit of Use]
HIBCC	B0672120C1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942249

FDA Product Code

• GWG: Endoscope, Neurological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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