This page includes the latest FDA filings for De Soutter Medical Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
De Soutter Medical Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3004007498 |
| FEI Number | 3004007498 |
| Name | DE SOUTTER MEDICAL USA, Inc |
| Owner & Operator | De Soutter Medical USA, Inc |
| Contact Address | 224 Rolling Hills Rd Ste 12A Mooresville NC 28117 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 224 Rolling Hills Rd Ste 12A Mooresville, NC 28117 US |
| Establishment Type | Repack or Relabel Medical Device |
Device Company | Device | Date |
|---|---|---|
DE SOUTTER MEDICAL USA, Inc | GatewayMed Arthroscopic Hand Instruments | 2009-12-07 |
| NCAGE Code | 413A7 | DE SOUTTER MEDICAL USA, INC |
| CAGE Code | 413A7 | DE SOUTTER MEDICAL USA, INC |
| S.A.M. Registration | 413A7 [119261290] | DE SOUTTER MEDICAL USA, INC |
| DUNS | 119261290 | De Soutter Medical USA, Inc |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020040313828 | London,United Kingdom -> New York, New York | POWER TOOLS FOR ORTHOPAEDIC SURGERY | 40 CTN |
| 2020032819667 | London,United Kingdom -> New York, New York | POWER TOOLS FOR ORTHOPAEDIC SURGERY | 40 CTN |
| 2020030735019 | London,United Kingdom -> New York, New York | POWER TOOLS FOR ORTHOPAEDIC SURGERY | 10 CTN |
| 2020030513067 | London,United Kingdom -> New York/Newark Area, Newark, New Jersey | PERSONAL EFFECTS | 1 PCS |
| 2020030436345 | London,United Kingdom -> New York, New York | POWER TOOLS FOR ORTHOPAEDIC SURGERY | 10 CTN |
| 2020022959216 | London,United Kingdom -> New York, New York | POWER TOOLS FOR ORTHOPAEDIC SURGERY | 4 CTN |
| 2020022132367 | London,United Kingdom -> New York/Newark Area, Newark, New Jersey | PERSONAL EFFECTS | 1 PCS |
| 2020022032218 | London,United Kingdom -> New York/Newark Area, Newark, New Jersey | PERSONAL EFFECTS | 1 PCS |