SAPPHIRE NC
ORBUSNEICH MEDICAL, INC.
ORBUSNEICH MEDICAL, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1064498 | 3014148220 | ORBUSNEICH MEDICAL, INC. | 1 | Y | 2026-01-01 | 3350 SW 148th Ave, Suite 110, Miramar, FL 33027, US Miramar FL US 33027 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 20677 | 2026341231 | K200269 | Sapphire II PRO | LOX | 2020-03-04 |
| 20677 | 1735207482 | K163114 | Sapphire II PRO | LOX | 2017-01-05 |
| 20677 | 1756066301 | K162209 | Sapphire NC Plus | LOX | 2016-10-06 |
| 20677 | 1910821440 | K103808 | SAPPHIRE NC | LOX | 2011-09-01 |
| 20677 | 1627244227 | K103657 | SAPPHIRE | LOX | 2011-08-09 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LOX | 5 | 2020-03-04 |
PMN#
SAPPHIRE
ORBUSNEICH MEDICAL, INC.