Primary Device ID | B042FG0005051 |
NIH Device Record Key | e690a18a-7226-4ec9-b235-f8980ff1abb0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ReTAP(TM) Cardiovascular Patch |
Version Model Number | FG0005-05 |
Catalog Number | FG0005-05 |
Company DUNS | 962898792 |
Company Name | SOLINAS MEDICAL 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 | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com | |
Phone | 650.427.9835 |
info@solinasmedical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B042FG0005051 [Primary] |
DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-10-23 |
B042FG0005091 | 10mm ID x 4.5cm length x 230 degrees |
B042FG0005071 | 9mm ID x 4.5cm length x 230 degrees |
B042FG0005051 | 8mm ID x 4.5cm length x 230 degrees |
B042FG0005031 | 7mm ID x 4.5cm length x 230 degrees |
B042FG0005011 | 6mm ID x 4.5cm length x 230 degrees |