TactiSys™ PN-004515

GUDID 07640157990064

ST. JUDE MEDICAL, INC.

Electrical-only medical device connection cable, reusable
Primary Device ID07640157990064
NIH Device Record Key886b2e16-5836-43c1-a7fd-17270f187d8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTactiSys™
Version Model NumberQuartz
Catalog NumberPN-004515
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 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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS107640157990064 [Primary]

FDA Product Code

OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-01
Device Publish Date2014-11-03

On-Brand Devices [TactiSys™]

07640157990316Quartz
07640157990217Quartz
07640157990194Equipment
07640157990187Quartz
07640157990064Quartz
07640157990057Quartz

Trademark Results [TactiSys]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TACTISYS
TACTISYS
85080190 3900774 Live/Registered
ENDOSENSE SA
2010-07-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.