Primary Device ID | 00763000114169 |
NIH Device Record Key | ce207d6d-db76-4e85-bb24-1cc9f0baedd0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | InterStim™ |
Version Model Number | 357506 |
Company DUNS | 796986144 |
Company Name | MEDTRONIC, INC. |
Device Count | 6 |
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 | true |
Serial Number | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000114169 [Unit of Use] |
GS1 | 20763000114163 [Primary] |
EZW | Stimulator, electrical, implantable, for incontinence |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-06-29 |
Device Publish Date | 2020-06-19 |
00763000114060 | NEEDLE 041839 FORAMN 5IN 20GA GLBL 2PK |
00763000114053 | NEEDLE 041838 FORAMN 3.5IN 20GA GLBL 6PK |
00763000114114 | LEAD 309201 ISTIM TEST STIM EMAN LF45 |
00763000114077 | LEAD 306001 ISTM PNE TST STM 1PK EMAN |
00763000114169 | CABLE 357506 MINI HOOK 6PK GLOBAL |
00763000114152 | CABLE 357501 MINI HOOK 1PK GLOBAL |
00763000203900 | ACCY 3560031 ISTM REVISION KIT |
00763000203894 | EXT 3560022 ISTM QUAD PERC 4.32MM |
00763000203887 | EXT 3560030 ISTM QUAD PERC 2.16MM |
00763000343323 | CABLE 367675 ISTM UNIPLR PAT 3W GLBL MDR |
00763000343316 | CABLE 357975 ISTM UNIPLR PAT 2W GLBL MDR |
00763000343279 | ACCY 041826 INTRSTIM GROUND PAD GLBL MDR |
00763000295547 | LEAD 309201 ISTIM TEST STIM EMAN LF45 |
00763000295523 | LEAD 306001 ISTIM PNE TEST STIM US |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTERSTIM 74469362 2072076 Live/Registered |
Medtronic, Inc. 1993-12-13 |