905-15

GUDID 05415067029805

Double-ended handle, 15mm sizer rings

ST. JUDE MEDICAL, INC.

Heart valve sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable
Primary Device ID05415067029805
NIH Device Record Keyf4da9a88-89c3-403b-bd91-5bef9edeb112
Commercial Distribution StatusIn Commercial Distribution
Version Model Number905-15
Catalog Number905-15
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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(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 Identifiers

Device Issuing AgencyDevice ID
GS105415067029805 [Primary]

FDA Product Code

DTISIZER, HEART-VALVE, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-11

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