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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10754026505021 [Primary] |
GS1 | 20754026505028 [Package] Package: Box [5 Units] Discontinued: 2021-06-30 In Commercial Distribution |
PDU | Catheter For Crossing Total Occlusions |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-06-15 |
Device Publish Date | 2021-04-30 |
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 |