SOUNDSTAR SNDSTR10G

GUDID 10846835000153

BIOSENSE WEBSTER INC.

Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use
Primary Device ID10846835000153
NIH Device Record Keyb6158bfe-5d38-43fe-95b9-57a4a2e87f2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOUNDSTAR
Version Model NumberSNDSTR10G
Catalog NumberSNDSTR10G
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

Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
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
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 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
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 out of direct sunlight
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
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 out of direct sunlight
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
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 out of direct sunlight
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
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 out of direct sunlight
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
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 out of direct sunlight
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS110846835000153 [Primary]

FDA Product Code

OBJCatheter, ultrasound, intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-01-15
Device Publish Date2016-09-16

On-Brand Devices [SOUNDSTAR]

1084683500886910439236
1084683500885210439011
1084683500884510439072
1084683500883810438577
10846835000153SNDSTR10G
10846835000139SNDSTR10

Trademark Results [SOUNDSTAR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOUNDSTAR
SOUNDSTAR
98272642 not registered Live/Pending
Soto, Emmanuel
2023-11-16
SOUNDSTAR
SOUNDSTAR
90845274 not registered Live/Pending
Gross, Richard
2021-07-23
SOUNDSTAR
SOUNDSTAR
87346288 5285752 Live/Registered
Arktura LLC
2017-02-22
SOUNDSTAR
SOUNDSTAR
76676528 3499491 Live/Registered
BIOSENSE WEBSTER, INC.
2007-05-07
SOUNDSTAR
SOUNDSTAR
75047080 2102104 Dead/Cancelled
SoundStar, LLC
1996-01-18
SOUNDSTAR
SOUNDSTAR
74655117 not registered Dead/Abandoned
Plantronics, Inc.
1995-03-31
SOUNDSTAR
SOUNDSTAR
73609415 1456227 Dead/Cancelled
HARRIS CORPORATION
1986-07-14

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