Primary Device ID | 17540265105022 |
NIH Device Record Key | bfd220b7-3f2b-453a-b82c-fd28622409d5 |
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 |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com | |
Phone | 1-833-312-9181 |
dominique.abecassis@soundbitemedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 17540265105022 [Primary] |
GS1 | 27540265205026 [Package] Package: Box [5 Units] In Commercial Distribution |
GS1 | 37540265305020 [Package] Contains: 27540265205026 Package: Box [10 Units] In Commercial Distribution |
PDU | Catheter For Crossing Total Occlusions |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-07-08 |
Device Publish Date | 2021-06-30 |
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 |