EZ Steer DS BD7TCFJ8L

GUDID 10846835002607

BIOSENSE WEBSTER INC.

Cardiac radio-frequency ablation system catheter
Primary Device ID10846835002607
NIH Device Record Keye83639c2-e37f-43c5-9ee6-eafead0e8024
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZ Steer DS
Version Model NumberBD7TCFJ8L
Catalog NumberBD7TCFJ8L
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
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry | Keep out of direct sunlight
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS110846835002607 [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 DS]

10846835002645BD7TCJJ8L
10846835002607BD7TCFJ8L
10846835002577BD7TCFF8L
10846835002539BD7TCDF8L
10846835002508BD7TCDD8L

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