AccessGUDID - DEVICE: SoundBite® Console (10754026503027)

GUDID

Device Identifier (DI) Information

Brand Name: SoundBite® Console
Version or Model: 9AB-C001091
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Soundbite Medical Solutions Inc

Primary DI Number: 10754026503027
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 208993667 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59224	Mechanical atherectomy system generator, mechanical output	A mains electricity (AC-powered) component of a mechanical atherectomy system designed to generate mechanical energy that is typically transmitted through a separate catheter/handpiece for the fragmentation of a chronic partial occlusion (CPO) or chronic total occlusion (CTO) of both coronary and peripheral arteries during an atherectomy procedure. The device may be operated via a remote control or foot-switch and may include an integrated suction/aspiration system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDU	Catheter For Crossing Total Occlusions

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210839	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 80 Kilogram
Width: 13 Inch
Height: 42 Inch
Depth: 22 Inch

Device Record Status

Public Device Record Key: a188048a-8e53-479c-8b7b-c43d3928d692
Public Version Date: June 30, 2021
Public Version Number: 3
DI Record Publish Date: April 30, 2021