| Primary Device ID | 00821684065747 |
| NIH Device Record Key | 60c9c93e-3404-4929-a13f-96c20b6ff232 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TurboHawkTM |
| Version Model Number | TH-LS-M |
| Company DUNS | 968903703 |
| Company Name | Covidien LP |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool dry place until ready for use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool dry place until ready for use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684065747 [Primary] |
| MCW | Catheter, peripheral, atherectomy |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00821684065747]
Ethylene Oxide
[00821684065747]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-26 |
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| 20884521703756 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521703770 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521822891 - DAR | 2024-12-09 Closed Suction System, Replaceable Catheter Endotracheal Length |
| 10884521845480 - Signia | 2024-12-09 SIGNIA CIRCULAR ADAPTER STND LENGTH FT |
| 10884521845497 - Signia | 2024-12-09 SIGNIA CIRCULAR ADAPTER XL LENGTH FT |
| 20884521581859 - Barrx | 2024-11-18 RFA Cleaning Cap Small |
| 20884521581866 - Barrx | 2024-11-18 RFA Cleaning Cap Medium |