LASSOSTAR Non-NAV -Circular navigation catheter D139002

GUDID 10846835020229

2.44FR LASSOSTAR non-NAV,10P,20MM

Biosense Webster Inc

Cardiac mapping catheter, percutaneous, single-use
Primary Device ID10846835020229
NIH Device Record Keyc3f9dfba-ce74-49c6-bbc1-47b2fc16704b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLASSOSTAR Non-NAV -Circular navigation catheter
Version Model NumberD139002
Catalog NumberD139002
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 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(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

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if use if box is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS110846835020229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

On-Brand Devices [LASSOSTAR Non-NAV -Circular navigation catheter]

108468350202432.44FR LASSOSTAR non-NAV,10P,25MM
108468350202362.44FR LASSOSTAR non-NAV,10P,15MM
108468350202292.44FR LASSOSTAR non-NAV,10P,20MM

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