| Primary Device ID | 00643169449145 |
| NIH Device Record Key | c904aca0-bcaf-4a5f-a3b1-594436e2eb38 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 3708640 |
| Company DUNS | 796986144 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| 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 |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Length | 40 Centimeter |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169449145 [Primary] |
| MRU | implanted subcortical electrical Stimulator (motor disorders) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2016-09-18 |
| 00199150003709 - Sphere-9™ Catheter | 2026-03-02 CATHETER AFR-00001 SPHERE 9 US GAL |
| 20763000558189 - CLOTtrac™ | 2026-03-02 CONTROL 550-01 CLOTTRAC CWB |
| 20763000558196 - CLOTtrac™ | 2026-03-02 CONTROL 550-07 CLOTTRAC HR 15BX |
| 20763000558202 - CLOTtrac™ | 2026-03-02 CONT 550-08 CLOTTRAC HR ABN BXD ASY |
| 20763000558219 - CLOTtrac™ | 2026-03-02 CONT 550-09 CLOTTRAC LR ABN BXD ASY |
| 20763000558226 - CLOTtrac™ | 2026-03-02 CONT 550-10 CLOTTRAC RACT ABN |
| 20763000558233 - CLOTtrac™ | 2026-03-02 CONTROL 550-12 CLOTTRAC HTC |
| 20763000558295 - RACT | 2026-03-02 CARTRIDGE 402-02 ACT RACT 17 LAN |