| Primary Device ID | 00681490862028 |
| NIH Device Record Key | 021bec61-55bd-4566-8713-5b8a4e317243 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 4806L50 |
| Company DUNS | 006261481 |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490862028 [Primary] |
| LPB | Cardiac ablation percutaneous catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
| 20763000558332 - HR HTC | 2026-03-03 CARTRIDGE 402-07 HR HTC BXD 20BX |
| 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 |