EZ Steer BD7TDF4L

GUDID 10846835002676

BIOSENSE WEBSTER INC.

Cardiac radio-frequency ablation system catheter
Primary Device ID10846835002676
NIH Device Record Key10ad4952-7a9f-4471-841c-bf51cc31cc38
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZ Steer
Version Model NumberBD7TDF4L
Catalog NumberBD7TDF4L
Company DUNS020163218
Company NameBIOSENSE WEBSTER 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(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS110846835002676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-06-28
Device Publish Date2014-09-10

On-Brand Devices [EZ Steer]

10846835002751BD7TJJ4L
10846835002720BD7TFJ4L
10846835002706BD7TFF4L
10846835002676BD7TDF4L
10846835002652BD7TDD4L
10846835002621BD7TCJJ4L
10846835002584BD7TCFJ4L
10846835002553BD7TCFF4L
10846835002515BD7TCDF4L
10846835002485BD7TCDD4L

Trademark Results [EZ Steer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EZ STEER
EZ STEER
88558534 not registered Live/Pending
Super ATV, LLC
2019-08-01
EZ STEER
EZ STEER
77730584 3838854 Dead/Cancelled
THE AMES COMPANIES, INC.
2009-05-06
EZ STEER
EZ STEER
76665927 3543965 Live/Registered
BIOSENSE WEBSTER, INC.
2006-09-11

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