RestorePRIME™
GUDID 00613994842299
INS 37701 RESTR PRIME BLUE TORQ WRNCH US
MEDTRONIC, INC.
Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system| Primary Device ID | 00613994842299 |
| NIH Device Record Key | 018127cd-c3d0-40c2-ab0b-ebd78f93ef50 |
| Commercial Distribution Discontinuation | 2016-08-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | RestorePRIME™ |
| Version Model Number | 37701 |
| 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 | 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 0 Degrees Fahrenheit and 126 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 126 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994842299 [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.
| 00763000951825 - NA | 2024-05-31 CUSTOM PACK SSBB12G88R STERILE SMPL |
| 00763000953423 - NA | 2024-05-31 CUSTOM PACK BB12F51R2 E ASSIST PACK |
| 00763000953614 - NA | 2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN |
| 00763000953621 - NA | 2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC |
| 00763000953638 - NA | 2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP |
| 00763000953645 - NA | 2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP |
| 20763000953663 - NA | 2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL |
| 00763000953676 - NA | 2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK |
Trademark Results [RestorePRIME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESTOREPRIME 78682980 3166759 Dead/Cancelled |
Medtronic, Inc. 2005-08-01 |
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