SJM Tailor™ TARP-35

GUDID 05414734007726

ST. JUDE MEDICAL, INC.

Mitral/tricuspid annuloplasty ring
Primary Device ID05414734007726
NIH Device Record Key810d0f33-7e76-424b-b959-7860e3ffdc4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSJM Tailor™
Version Model NumberANNULOPLASTY RING
Catalog NumberTARP-35
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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

Device Dimensions

Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the double-barrier tray in a cool, dry place until needed

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734007726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRHRING, ANNULOPLASTY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-01-07

On-Brand Devices [SJM Tailor™]

05414734055727Annuloplasty Band
05414734055710Annuloplasty Band
05414734055703Annuloplasty Band
05414734055697Annuloplasty Band
05414734055680Annuloplasty Band
05414734055673Annuloplasty Band
05414734010085Annuloplasty Ring Sizer Set
05414734007726ANNULOPLASTY RING
05414734007719ANNULOPLASTY RING
05414734007702ANNULOPLASTY RING
05414734007696ANNULOPLASTY RING
05414734007689Annuloplasty Ring
05414734007672ANNULOPLASTY RING
05415067044617Annuloplasty Band
05415067044556Annuloplasty Band
05415067044532Annuloplasty Band
05415067044518Annuloplasty Band
05415067044495Annuloplasty Ring
05415067044457Annuloplasty Ring
05415067044396Annuloplasty Ring

Trademark Results [SJM Tailor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SJM TAILOR
SJM TAILOR
76440640 2721243 Live/Registered
St. Jude Medical, Inc.
2002-08-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.