RestoreAdvanced® SureScan®
GUDID 00643169109490
INS 97713 RESTORE ADVANCED MRICS
MEDTRONIC, INC.
Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable| Primary Device ID | 00643169109490 |
| NIH Device Record Key | 03a0728d-7c05-4649-8b1c-33501b74fec8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RestoreAdvanced® SureScan® |
| Version Model Number | 97713 |
| 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
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169109490 [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 | 2014-09-23 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000960308 - NA | 2024-07-09 CUSTOM PACK BB12C30R7 NPR IMC |
| 00763000960407 - NA | 2024-07-09 CUSTOM PACK BB12G16R3 UCHICAGO CPB |
| 00763000228699 - NA | 2024-07-08 KIT 20MRK ARCTIC FRNT MANETRACT GLB TIJ |
| 00763000957193 - NA | 2024-07-08 CUSTOM PACK BB7M46R25 SCV ADLT |
| 20763000960272 - NA | 2024-07-08 CUSTOM PACK 10R91R5 10PK LRTXBYPS |
| 20763000960296 - NA | 2024-07-08 CUSTOM PACK SSBB12D06R4 4PK RESOXY BYPA |
| 00763000879273 - Verify™ | 2024-07-05 ENS 353101 VERIFY ISTM US EMANUAL |
| 00763000879280 - Verify™ | 2024-07-05 ENS 353101 VERIFY ISTM US REFURB EMAN |
Trademark Results [RestoreAdvanced]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESTOREADVANCED 78709749 3204643 Live/Registered |
Medtronic, Inc. 2005-09-09 |
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