| 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 |