InterStim™
GUDID 00763000114114
LEAD 309201 ISTIM TEST STIM EMAN LF45
MEDTRONIC, INC.
Sacral plexus percutaneous incontinence-control electrical stimulation system electrode| Primary Device ID | 00763000114114 |
| NIH Device Record Key | 99666d03-f393-4ba3-b018-350a8371ea32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InterStim™ |
| Version Model Number | 309201 |
| Company DUNS | 796986144 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 12 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000114114 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P080025
FDA Product Code
| EZW | Stimulator, electrical, implantable, for incontinence |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2020-03-05 |
On-Brand Devices [InterStim™]
| 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 |
Trademark Results [InterStim]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERSTIM 74469362 2072076 Live/Registered |
Medtronic, Inc. 1993-12-13 |
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