405545

GUDID 05415067004796

Vessel Dilator

ST. JUDE MEDICAL, INC.

Vascular dilator, single-use
Primary Device ID05415067004796
NIH Device Record Key8235d163-3064-444c-9dfa-3466bb3439e9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number405545
Catalog Number405545
Company DUNS149818952
Company NameST. JUDE MEDICAL, 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter
Catheter Gauge4 French
Length15 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067004796 [Previous]
GS105415067042798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-24
Device Publish Date2022-02-16

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