GUDID 00643169014206

INTRDCR 673311 10PK 7F 11CM STDLNE DIALA

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID00643169014206
NIH Device Record Key6c9a3de2-1417-4e79-a6bc-c82aab361219
Commercial Distribution StatusIn Commercial Distribution
Version Model Number673311
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 Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter
Outer Diameter0.97 Millimeter
Catheter Gauge7 French
Length11 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169014206 [Primary]
GS120643169014200 [Package]
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 Date2016-08-25

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