INTERSTIM
GUDID 00613994601964
LEAD 3889-33 TINED QUAD SNS US
MEDTRONIC, INC.
Neural-tissue electrical stimulation lead Neural-tissue electrical stimulation lead Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode Sacral plexus implantable incontinence-control electrical stimulation system electrode| Primary Device ID | 00613994601964 |
| NIH Device Record Key | 8a52bae6-0e85-4207-8490-3b208f8b873a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTERSTIM |
| Version Model Number | 3889-33 |
| 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 | 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
| Length | 33 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994601964 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970004
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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [INTERSTIM]
| 00613994601964 | LEAD 3889-33 TINED QUAD SNS US |
| 00613994601957 | LEAD 3889-28 TINED QUAD SNS US |
| 00613994601940 | LEAD 3093-41 TINED QUAD EXT ELECT SNS US |
| 00613994601926 | LEAD 3093-28 TINED QUAD EXT ELECT SNS US |
| 00613994572042 | LEAD 3057-1SC TEST SCREENER 1PK US BOWEL |
| 00613994572011 | ACC 3065USC PNE KIT ETO US BOWEL |
| 00613994571977 | EXTN 3095-10 KIT QD INLINE US 10CM BOWEL |
| 00613994571960 | EXTN 3095-25 KIT QD INLINE US 25CM BOWEL |
| 00613994571946 | EXTN 3095-51 KIT QD INLINE US 51CM BOWEL |
| 00613994141996 | PNE Kit, 3065USC, InterStim, US |
Trademark Results [INTERSTIM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERSTIM 74469362 2072076 Live/Registered |
Medtronic, Inc. 1993-12-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.