RAFAEL MEDICAL DEVICES, LLC
FDA Registration(s)#
Registration, FEI, Name table| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|
| 3018821071 | 3018821071 | RAFAEL MEDICAL DEVICES, LLC | 1 | N | 2026-01-01 | 520 Broad St Newark NJ US 07102 |
Registered Device Listings#
Registration key, Listing key, Premarket submission table| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|
| 334859 | 1912898964 | K242417 | VECTR – Video Endoscopic Carpal Tunnel Release System | HRX | 2024-12-11 |
| 334859 | 1123122658 | | | | |
| 334859 | 1970692955 | | | | |
Product Codes Associated With Registrations#
Product code, Registration listing records, Latest decision table| Product code | Registration listing records | Latest decision |
|---|
| HRX | 1 | 2024-12-11 |
PMN#
2024-12-11
Rafael Medical Devices, LLC
GUDID#
Rafael Medical Devices, LLC
2025-01-13
Rafael Medical Devices, LLC
2025-01-10