TurboHawk™
GUDID 00643169968226
ATHERECTOMY THS-SX-C TURBOHAWK BTK HEC U
Covidien LP
Mechanical atherectomy system catheter, peripheral| Primary Device ID | 00643169968226 |
| NIH Device Record Key | 11f25ec4-b6a4-4b36-9c65-20532386ec3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TurboHawk™ |
| Version Model Number | THS-SX-C |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169968226 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| MCW | Catheter, peripheral, atherectomy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-31 |
On-Brand Devices [TurboHawk™]
| 00643169968226 | ATHERECTOMY THS-SX-C TURBOHAWK BTK HEC U |
| 00643169968202 | ATHERECTOMY THS-SS-CL TURBOHAWK BTK HECU |
| 00821684074008 | ATHERECTOMY THS-LX-C TURBOHAWK ATK V08 |
| 00821684065853 | ATHERECTOMY THS-SX-C TURBOHAWK BTK V03 |
| 00821684065839 | ATHERECTOMY THS-SS-CL TURBOHAWK BTK V03 |
| 00821684065815 | ATHERECTOMY THS-SS-C TURBOHAWK BTK V03 |
| 00821684065785 | ATHERECTOMY THS-LS-C TURBOHAWK ATK V08 |
| 00821684065754 | ATHERECTOMY TH-LX-M TURBOHAWK ATK V06 |
Trademark Results [TurboHawk]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TURBOHAWK 77793330 3832940 Live/Registered |
COVIDIEN LP 2009-07-30 |
 TURBOHAWK 75331017 2293271 Dead/Cancelled |
Concurrent Computer Corporation 1997-07-25 |
 TURBOHAWK 73682804 1486986 Dead/Cancelled |
AMERICAN PLASTIC TOYS, INC. 1987-09-08 |
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