GUDID 20643169014378

INTRDCR 040042A 10PK 17CM 6F DILATOR

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID20643169014378
NIH Device Record Key42989ce0-c03e-4ce6-9967-1d91ae86962b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number040042A
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
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter
Catheter Gauge6 French
Outer Diameter0.97 Millimeter
Length11 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169014374 [Primary]
GS120643169014378 [Package]
Contains: 00643169014374
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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