HawkOne™

GUDID 00763000202699

ATHERECTOMY H1-14550 CUTTER DRIVER US

Covidien LP

Mechanical atherectomy system catheter, peripheral
Primary Device ID00763000202699
NIH Device Record Key7aeb6e5f-8e82-4cf4-b781-5a75529c5f65
Commercial Distribution StatusIn Commercial Distribution
Brand NameHawkOne™
Version Model NumberH1-14550
Company DUNS968903703
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000202699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, peripheral, atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-30
Device Publish Date2019-04-22

On-Brand Devices [HawkOne™]

00643169968554ATHERECTOMY H1-14550 CUTTER DRIVER UNI
00643169968509ATHERECTOMY H1-LX HAWKONE 7F EXT TIP US
00643169968486ATHERECTOMY H1-LS HAWKONE 7F STD TIP US
00643169968356ATHERECTOMY H1-S HAWKONE 6F US
00643169968332ATHERECTOMY H1-M HAWKONE 6F US
00643169792319ATHERECTOMY H1-S US HAWKONE V02
00643169792302ATHERECTOMY H1-M US HAWKONE V02
00643169777644ATHERECTOMY H1-14550 CUTTER DRIVER V03
00643169728783ATHERECTOMY H1-S US HAWKONE V01
00643169728769ATHERECTOMY H1-M US HAWKONE V01
00763000202699ATHERECTOMY H1-14550 CUTTER DRIVER US

Trademark Results [HawkOne]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAWKONE
HAWKONE
86284715 4787076 Live/Registered
Covidien LP
2014-05-19

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