NeuroPEN

GUDID 00613994840233

NEUROPEN 2120-025 15MM 15.5 DF .045

MEDTRONIC PS MEDICAL, INC.

Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use

• Primary Device ID: 00613994840233
• NIH Device Record Key: bc743f6a-d0c9-47e7-9280-4c5ef717a7ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPEN
• Version Model Number: 2120-025
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, INC.
• 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: false
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994840233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003914

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: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-06-13

On-Brand Devices [NeuroPEN]

• 00613994908490: NEUROPEN 2120-035 15MM 19CM DF
• 00613994840233: NEUROPEN 2120-025 15MM 15.5 DF .045
• 00643169498051: FORCEPS 3220-001 BIOPSY 3MM L 28.5CM
• 00721902879784: NEUROPEN 27769 W/NO EPOXY OVER END