TurboHawk™ Plus
GUDID 00763000402396
ATHERECTOMY THP-M TH PLUS 6F US
MEDTRONIC, INC.
Mechanical atherectomy system catheter, peripheral| Primary Device ID | 00763000402396 |
| NIH Device Record Key | a8e1369d-e930-47c4-9c35-896857e35de6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TurboHawk™ Plus |
| Version Model Number | THP-M |
| 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 | 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 |
Device Dimensions
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
| Balloon Diameter | 2.2 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 6 French |
| Length | 129 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| 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 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000402396 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212027
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 | 1 |
| Public Version Date | 2021-10-04 |
| Device Publish Date | 2021-09-26 |
On-Brand Devices [TurboHawk™ Plus]
| 00763000402419 | ATHERECTOMY THP-S TH PLUS 6F US |
| 00763000402396 | ATHERECTOMY THP-M TH PLUS 6F US |
| 00763000402372 | ATHERECTOMY THP-LS TH PLUS 7F STD TIP US |
| 00763000402358 | ATHERECTOMY THP-LX TH PLUS 7F EXT TIP US |
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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