GUDID 20643169116003

INTRODUCER 683323 10PK 8F 23CM 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 ID20643169116003
NIH Device Record Key0e3a0722-00a2-403a-8a2c-94d5cd31cd01
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number683323
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

Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French
Outer Diameter0.97 Millimeter
Length23 Centimeter
Catheter Gauge8 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169116009 [Primary]
GS120643169116003 [Package]
Contains: 00643169116009
Package: PK [10 Units]
Discontinued: 2018-10-05
Not 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 Number5
Public Version Date2019-06-07
Device Publish Date2016-08-20

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