GUDID 20643169014224

INTRDCR 653311 10PK 5F 11CM STDLNE DIALT

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID20643169014224
NIH Device Record Key50572873-f92a-4e20-be6d-e7d154b8784b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number653311
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length11 Centimeter
Length11 Centimeter
Length11 Centimeter
Length11 Centimeter
Length11 Centimeter
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge5 French
Length11 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169014220 [Primary]
GS120643169014224 [Package]
Contains: 00643169014220
Package: PK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2017-02-02

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