SureTune™ 4
GUDID 00763000421212
SW B36104S SURETUNE4 DBS SERVER
MEDTRONIC, INC.
Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software Implantable electrical stimulation device management software| Primary Device ID | 00763000421212 |
| NIH Device Record Key | 4bbe085f-1283-4503-a133-7da7dff4c7a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureTune™ 4 |
| Version Model Number | B36104S |
| 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 | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000421212 [Direct Marking] |
| GS1 | 00763000496432 [Primary] |
| GS1 | 00763000496449 [Primary] |
| GS1 | 00763000496456 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN210003
FDA Product Code
| QQC | Brain stimulation programming planning software. |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-01 |
| Device Publish Date | 2021-10-22 |
Devices Manufactured by MEDTRONIC, INC.
| 20763000950280 - NA | 2024-05-07 CUSTOM PACK BB10N53R3 5PK ACCESSORY |
| 00763000950699 - NA | 2024-05-07 CUSTOM PACK 5D56R9 NEURO FLOWS |
| 00763000841591 - Cardioblate™ Gemini™-s | 2024-05-06 CARDIOBLATE GEMINI-S 49260 EN |
| 00763000949341 - NA | 2024-05-06 CUSTOM PACK BB12A73R5 AV LOOP |
| 20763000949369 - NA | 2024-05-06 CUSTOM PACK BB12F71R2 4PK LOYOLA CPG |
| 00763000949372 - NA | 2024-05-06 CUSTOM PACK BB11L23R8 UTMC SUPP PK |
| 20763000950105 - NA | 2024-05-06 CUSTOM PACK BB12G65R 5PK TAPER |
| 00763000950118 - NA | 2024-05-06 CUSTOM PACK CB3Z71R24 PRIMARY |
Trademark Results [SureTune]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURETUNE 97101989 not registered Live/Pending |
Medtronic Bakken Research Center B.V. 2021-11-01 |
 SURETUNE 88110798 not registered Live/Pending |
Medtronic Bakken Research Center B.V. 2018-09-10 |
 SURETUNE 85521008 4209278 Dead/Cancelled |
Sapiens Steering Brain Stimulation B.V. 2012-01-20 |
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