SoundBite® Curving Tool 14
GUDID 10754026505021
The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU.
Soundbite Medical Solutions Inc
Surgical probe/cannula bending tool| Primary Device ID | 10754026505021 |
| NIH Device Record Key | fcef0dea-7f67-4975-83cf-ee5b047473ca |
| Commercial Distribution Discontinuation | 2021-06-30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SoundBite® Curving Tool 14 |
| Version Model Number | 900-0001291 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10754026505021 [Primary] |
| GS1 | 20754026505028 [Package] Package: Box [5 Units] Discontinued: 2021-06-30 In Commercial Distribution |
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 | true |
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® Curving Tool 14]
| 10754026505021 | The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if |
| 17540265105022 | The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if |
Trademark Results [SoundBite]
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