RestoreUltra®SureScan®
GUDID 00643169553125
INS 97712 RSTRULTRA SS MRI EMAN COQUIPUL
MEDTRONIC, INC.
Analgesic spinal cord electrical stimulation system| Primary Device ID | 00643169553125 |
| NIH Device Record Key | a04c6eb3-acc7-4004-b46d-516c82d1e3e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RestoreUltra®SureScan® |
| Version Model Number | 97712 |
| Company DUNS | 796986144 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 125 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169553125 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P840001
FDA Product Code
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
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 | 2016-05-08 |
Devices Manufactured by MEDTRONIC, INC.
| 10681490185162 - NA | 2026-01-21 POUCH 8590-1 SYNCHROMED PUMP US |
| 00763000300623 - N/A | 2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM |
| 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 |
Trademark Results [RestoreUltra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESTOREULTRA 78903139 3433265 Live/Registered |
Medtronic, Inc. 2006-06-07 |
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