TurboHawkTM

GUDID 00821684065747

ATHERECTOMY TH-LS-M TURBOHAWK ATK V06

Covidien LP

Mechanical atherectomy system catheter, peripheral
Primary Device ID00821684065747
NIH Device Record Key60c9c93e-3404-4929-a13f-96c20b6ff232
Commercial Distribution StatusIn Commercial Distribution
Brand NameTurboHawkTM
Version Model NumberTH-LS-M
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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 Identifiers

Device Issuing AgencyDevice ID
GS100821684065747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, peripheral, atherectomy

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00821684065747]

Ethylene Oxide


[00821684065747]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-08-26

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