PrimeAdvanced® SureScan®
GUDID 00643169109513
INS 97702 RESTORE PRIME ADVANCED MRICS
MEDTRONIC, INC.
Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system| Primary Device ID | 00643169109513 |
| NIH Device Record Key | d9c16bc3-1ac3-4483-b136-2d5870d9753b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PrimeAdvanced® SureScan® |
| Version Model Number | 97702 |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169109513 [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.
| 00763000894689 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB6MP1K SB 6F 55CM MP1 |
| 00763000894726 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB6MPHK SB 55CM MPH |
| 00763000894801 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB6PK1W SB 6F 47CM PK1 |
| 00763000894917 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB6RDCK SB 6F 55CM RDC |
| 00763000895754 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB7IMAK SB 7F 55CM IMA |
| 00763000901905 - Launcher™ | 2024-06-07 CATHETER LA8NOTOSH LA 8F 100CM NOTO |
| 00763000902230 - Launcher™ | 2024-06-07 CATHETER LA8SCR35SH LA 8F 100CM SCR35 |
| 00763000902520 - Launcher™ | 2024-06-07 CATHETER LA83DRC LA 8F 100CM 3DRC |
Trademark Results [PrimeAdvanced]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRIMEADVANCED 78709773 3204644 Live/Registered |
Medtronic, Inc. 2005-09-09 |
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