HawkOne™
GUDID 00643169728769
ATHERECTOMY H1-M US HAWKONE V01
Covidien LP
Mechanical atherectomy system catheter, peripheral| Primary Device ID | 00643169728769 |
| NIH Device Record Key | 3dc49294-a88a-4549-a604-f7759d7d5ff2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HawkOne™ |
| Version Model Number | H1-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 | false |
| 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 |
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 |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 129 Centimeter |
| Outer Diameter | 2.2 Millimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169728769 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161361
FDA Product Code
| MCW | Catheter, peripheral, atherectomy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-29 |
On-Brand Devices [HawkOne™]
| 00643169968554 | ATHERECTOMY H1-14550 CUTTER DRIVER UNI |
| 00643169968509 | ATHERECTOMY H1-LX HAWKONE 7F EXT TIP US |
| 00643169968486 | ATHERECTOMY H1-LS HAWKONE 7F STD TIP US |
| 00643169968356 | ATHERECTOMY H1-S HAWKONE 6F US |
| 00643169968332 | ATHERECTOMY H1-M HAWKONE 6F US |
| 00643169792319 | ATHERECTOMY H1-S US HAWKONE V02 |
| 00643169792302 | ATHERECTOMY H1-M US HAWKONE V02 |
| 00643169777644 | ATHERECTOMY H1-14550 CUTTER DRIVER V03 |
| 00643169728783 | ATHERECTOMY H1-S US HAWKONE V01 |
| 00643169728769 | ATHERECTOMY H1-M US HAWKONE V01 |
| 00763000202699 | ATHERECTOMY H1-14550 CUTTER DRIVER US |
Trademark Results [HawkOne]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HAWKONE 86284715 4787076 Live/Registered |
Covidien LP 2014-05-19 |
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