GUDID 00763000875749

PROG 97745FA-RFB INTELLIS PTM REFURB US

MEDTRONIC, INC.

Multiple active implantable device programmer

• Primary Device ID: 00763000875749
• NIH Device Record Key: 10c4519b-f190-44ae-95f2-9bcda9656749
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 97745FA-RFB
• Company DUNS: 796986144
• Company Name: MEDTRONIC, 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: false
• Lot Batch: false
• Serial Number: true
• 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
• 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

• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000875749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

• QRB: Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-24
• Device Publish Date: 2023-11-16

Devices Manufactured by MEDTRONIC, INC.

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• 00763000596958 - InterStim™ SureScan™: 2026-01-08 LEAD 978B133 ISTM SSMRI 4.32MM EMAN GLBL
• 00763000596996 - InterStim™ SureScan™: 2026-01-08 LEAD 978B141 ISTM SSMRI 4.32MM EMAN GLBL
• 00763000994198 - N/A: 2026-01-07 ACCY KIT 3550-68 TWIST LOCK SCRN CBL MDR
• 00199150065684 - NA: 2026-01-06 CUSTOM PACK BB11W65R6 HLO SPECTRUM
• 00199150065691 - NA: 2026-01-06 CUSTOM PACK BB6V93R18 EVL A 3/8 E
• 00199150065745 - NA: 2026-01-06 CUSTOM PACK BB10V37R6 EVL 1/4 PED
• 20199150065763 - NA: 2026-01-06 CUSTOM PACK BB11V27R2 10PK ACC 3/8 CONN