GUDID 20613994939245

CATH 218445 PF 5PK KIT6F ST XT CHOICE PK

MEDTRONIC, INC.

Angiographic catheter, single-use
Primary Device ID20613994939245
NIH Device Record Key6d07daac-fcdc-448b-a3de-f841ebb68e63
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number218445
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 Kittrue
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
GS100613994939241 [Primary]
GS120613994939245 [Package]
Contains: 00613994939241
Package: PK [5 Units]
Discontinued: 2018-10-05
Not 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 Number4
Public Version Date2019-01-30
Device Publish Date2016-07-03

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