GUDID 20613994941828

CATH 018418 PF 5PK KIT6F ST XT ANGIO KIT

MEDTRONIC, INC.

Angiographic catheter, single-use
Primary Device ID20613994941828
NIH Device Record Keye39b0687-de1c-4043-a3e6-d35862ed1629
Commercial Distribution StatusIn Commercial Distribution
Version Model Number018418
Company DUNS006261481
Company NameMEDTRONIC, INC.
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

Device Dimensions

Catheter Gauge6 French
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry area.

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994941824 [Primary]
GS120613994941828 [Package]
Contains: 00613994941824
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-13

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