Channel

GUDID 00643169103566

NEUROENDOSCOPE 2232-001 CHANNEL 4.5

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: 00643169103566
• NIH Device Record Key: c165e301-7332-4e65-96a1-eb95540a9fcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Channel
• Version Model Number: 2232-001
• 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

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	00643169103566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002572

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 [Channel]

• 00613994840240: CHANNELSCOPE 2233-005 30K 13 CM
• 00643169103597: NEUROENDOSCP 2232-004 CHANNEL 3.5 L 13
• 00643169103580: NEUROENDOSCP 2232-003 CHANNEL 4.5 L 13
• 00643169103573: NEUROENDOSCOPE 2232-002 CHANNEL 3.5
• 00643169103566: NEUROENDOSCOPE 2232-001 CHANNEL 4.5
• 00613994965622: CHANNELSCOPE 2233-002 30K 21.6 LNG