TUNNELER REPLACEMENT TIP, DISSECTING 10002-6099-002

GUDID 00813024011538

Thoratec Corporation

Vascular graft tunneller
Primary Device ID00813024011538
NIH Device Record Keyf1c5bcc9-5d4b-4067-a4e9-8d052b96b031
Commercial Distribution StatusIn Commercial Distribution
Brand NameTUNNELER REPLACEMENT TIP, DISSECTING
Version Model Number10002-6099-002
Catalog Number10002-6099-002
Company DUNS070156955
Company NameThoratec Corporation
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813024011477 [Primary]
GS100813024011538 [Direct Marking]

FDA Product Code

DSQVentricular (Assisst) Bypass
DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813024011538]

Moist Heat or Steam Sterilization


[00813024011538]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-03-21
Device Publish Date2014-09-20

Devices Manufactured by Thoratec Corporation

15415067038279 - HeartMate™2022-09-20 ICU Cover
05415067042439 - CentriMag™2022-09-07 System Transporter
05415067038760 - HeartMate 3™2022-06-22 Coring Tool
05415067039286 - HeartMate 3™2022-06-22 Apical Cuff
05415067039361 - HeartMate 3™2022-06-22 Skin Coring Punch
15415067039481 - HeartMate 3™2022-06-22 Thread Protectors
05415067033758 - HeartMate Touch™2020-07-02 Communication System
05415067032058 - HeartMate Touch™2020-05-12 Communication System

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