GUDID 20613994802518

PROBE PSP1002 10PK 230MM BALL TIP ROHS

MEDTRONIC XOMED, INC.

Nerve-locating system, line-powered

• Primary Device ID: 20613994802518
• NIH Device Record Key: e8cf42f2-fc02-4e4c-9d42-be3cd448752f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PSP1002
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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

Device Dimensions

• Length: 2 Meter
• Length: 2 Meter
• Length: 2 Meter
• Length: 2 Meter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994802514 [Primary]
GS1	20613994802518 [Package]; Contains: 00613994802514; Package: PK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062996

FDA Product Code

• GXZ: ELECTRODE, NEEDLE

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: 2016-04-30

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00763000842543 - Bipolar Stimulating Probe: 2024-11-04 PROBE 8225351 5PK CONCEN BIPO STIM ROHS
• 00763000842550 - Bipolar Stimulating Probe: 2024-11-04 PROBE 8225401 5PK SD-SD BIPOL STIM ROHS
• 00763000842567 - Bipolar Stimulating Probe: 2024-11-04 PROBE 8225451 5PK PRASS BIPO STIMUL ROHS
• 00763000891862 - ENT NIM Electrode: 2024-10-01 PROBE 8225275 BALL TIP 1MM ROHS
• 00763000891879 - ENT NIM Electrode: 2024-10-01 PROBE 8225276 BALL TIP 2.3MM ROHS
• 00763000580483 - ENT NIM Vital: 2024-09-27 CABLE 1352415 STIM DISSECTION 3M ROHS
• 00763000578022 - N/A: 2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL
• 00763000578039 - N/A: 2024-09-24 SPLINT 1528111 5PK EXTERNAL NASAL SMALL