INTERSTIM® II
GUDID 00643169974760
INS 3058 INTERSTIM II EMAN US GRC
MEDTRONIC, INC.
Implantable incontinence-control electrical stimulation system pulse generator| Primary Device ID | 00643169974760 |
| NIH Device Record Key | 837a5598-7ceb-406d-9721-9a8ef5ae2b1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTERSTIM® II |
| Version Model Number | 3058 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169974760 [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 | 2019-06-03 |
| Device Publish Date | 2019-05-24 |
Devices Manufactured by MEDTRONIC, INC.
| 20763000984193 - NA | 2024-11-18 CUSTOM PACK BB12F71R5 4PK LOYOLA CPG |
| 20763000982946 - NA | 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD |
| 00763000984007 - NA | 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG |
| 00763000984021 - NA | 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE |
| 00763000984151 - NA | 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT |
| 00763000984168 - NA | 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS |
| 00763000984175 - NA | 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK |
| 00763000180010 - Sprint Quattro Secure S™ | 2024-11-12 LEAD 693552 SPRINT US RCMCRD |
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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