GUDID 20643169014057

INTRDCR 205211A 10PK 5F 11CM INPT OBT

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID20643169014057
NIH Device Record Key0eeaf8c1-4c27-4aa6-a40e-e5ff50da46c4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number205211A
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 Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French
Length11 Centimeter
Catheter Gauge5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169014053 [Primary]
GS120643169014057 [Package]
Contains: 00643169014053
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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