SoundBite® Console
GUDID 10754026503027
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 Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output| Primary Device ID | 10754026503027 |
| NIH Device Record Key | a188048a-8e53-479c-8b7b-c43d3928d692 |
| Commercial Distribution Discontinuation | 2021-06-30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SoundBite® Console |
| Version Model Number | 9AB-C001091 |
| Company DUNS | 208993667 |
| Company Name | Soundbite Medical Solutions Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
| Weight | 80 Kilogram |
| Width | 13 Inch |
| Height | 42 Inch |
| Depth | 22 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10754026503027 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210839
FDA Product Code
| PDU | Catheter For Crossing Total Occlusions |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-06-15 |
| Device Publish Date | 2021-04-30 |
On-Brand Devices [SoundBite® Console]
| 10754026503027 | The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i. |
| 17540265103028 | The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i. |
Trademark Results [SoundBite]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.