406500

GUDID 05415067042811

Repositioning Sleeve

ST. JUDE MEDICAL, INC.

Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath Cardiovascular catheter sheath
Primary Device ID05415067042811
NIH Device Record Keye39fecac-de87-4f56-88b8-7748aed9c831
Commercial Distribution StatusIn Commercial Distribution
Version Model Number406500
Catalog Number406500
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

Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry and dark area

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734026505 [Previous]
GS105415067042811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQRCANNULA, CATHETER

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

Devices Manufactured by ST. JUDE MEDICAL, INC.

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05415067050021 - EnSite™2024-04-04 X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
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