FDA Registration
Active
🇺🇸 United States
SURGICAL DIRECT, INC.
Reg #: 3003687489
·
FEI: 3003687489
·
Expires 2026
Products
29
Proprietary Names
1
Establishment Types
1
Classifications
29
Registration Details
- Registration Name
- SURGICAL DIRECT, INC.
- Registration Number
- 3003687489
- FEI Number
- 3003687489
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 811 Harley Strickland Blvd
- City
- Orange City
- State
- FL
- ZIP
- 32763
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193018
Owner / Operator
- Firm Name
- SURGICAL DIRECT, INC.
- Operator Number
- 9051277
- Address
- 811 Harley Strickland Blvd, --
- City
- Orange City
- State
- FL
- Postal Code
- 32763
- Country
- US
- Correspondent
- JAMES D MURRAY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2019-12-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2018-08-01 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2020-10-27 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-10-27 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2024-12-04 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2018-08-01 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2024-12-04 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2020-10-27 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2018-08-01 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2024-12-04 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2024-12-04 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2024-12-04 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2018-08-01 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2024-12-04 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2018-08-01 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2024-12-04 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2024-12-04 |
Proprietary Names
Surgical Direct
Establishment Types
Repack or Relabel Medical Device