SoundBite® Console

GUDID 17540265103028

The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position.

Soundbite Medical Solutions Inc

Mechanical atherectomy system generator, mechanical output
Primary Device ID17540265103028
NIH Device Record Keyb33bddab-abc1-43ee-baa5-205963682a40
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoundBite® Console
Version Model Number9AB-C001091
Company DUNS208993667
Company NameSoundbite Medical Solutions 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 Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com
Phone1-833-312-9181
Emaildominique.abecassis@soundbitemedical.com

Device Dimensions

Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch
Weight80 Kilogram
Width13 Inch
Height42 Inch
Depth22 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS117540265103028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDUCatheter For Crossing Total Occlusions

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-08
Device Publish Date2021-06-30

On-Brand Devices [SoundBite® Console]

10754026503027The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.
17540265103028The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.

Trademark Results [SoundBite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOUNDBITE
SOUNDBITE
90656983 not registered Live/Pending
Soundbite Inc.
2021-04-20
SOUNDBITE
SOUNDBITE
88134216 not registered Live/Pending
Iizuna Cider LLC
2018-09-27
SOUNDBITE
SOUNDBITE
87887866 5778972 Live/Registered
SoundBite Magazine LLC
2018-04-22
SOUNDBITE
SOUNDBITE
87580823 5457726 Live/Registered
SONITUS MEDICAL (SHANGHAI) CO., LTD.
2017-08-23
SOUNDBITE
SOUNDBITE
87230701 5222950 Live/Registered
Gonzalez, Daniel A
2016-11-08
SOUNDBITE
SOUNDBITE
87081309 not registered Live/Pending
Soundbite Medical Solutions Inc.
2016-06-23
SOUNDBITE
SOUNDBITE
85217218 not registered Dead/Abandoned
Sonitus Medical, Inc.
2011-01-13
SOUNDBITE
SOUNDBITE
85091380 3934412 Dead/Cancelled
SOUNDBITE TECHNOLOGY, LLC
2010-07-23
SOUNDBITE
SOUNDBITE
77855295 not registered Dead/Abandoned
Sonitus Medical Inc.
2009-10-22
SOUNDBITE
SOUNDBITE
77603448 not registered Dead/Abandoned
SoundBite Dental, LLC
2008-10-29
SOUNDBITE
SOUNDBITE
76662065 not registered Dead/Abandoned
HASBRO, INC.
2006-06-12
SOUNDBITE
SOUNDBITE
76058914 2791788 Live/Registered
GENESYS TELECOMMUNICATIONS LABORATORIES, INC.
2000-05-30

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