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 |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00613994842299 [Primary] |
LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2014-09-23 |
20763000825212 - NA | 2024-03-25 CUSTOM PACK SS12B17R1 5PK CHANGEOUT |
00763000825324 - NA | 2024-03-25 78.800 |
00763000940300 - NA | 2024-03-25 CUSTOM PACK BB6H26R45 ADULT CK |
00763000941055 - NA | 2024-03-25 CUSTOM PACK HY9M47R20 ADLT MAIN |
20763000941073 - NA | 2024-03-25 CUSTOM PACK BB12G07R 5PK ACC LINE |
00763000941086 - NA | 2024-03-25 CUSTOM PACK BB12F62R2 UOFU HEART PA |
00763000941093 - NA | 2024-03-25 CUSTOM PACK HY8B05R11 HBC |
00763000941352 - NA | 2024-03-25 CUSTOM PACK BB12F31R E TRANS |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RESTOREPRIME 78682980 3166759 Dead/Cancelled |
Medtronic, Inc. 2005-08-01 |