FDA Registration
Active
🇺🇸 United States
Brasseler U.S.A. Medical, LLC
Reg #: 2025102
·
FEI: 3004949275
·
Expires 2026
Products
14
Proprietary Names
14
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- Brasseler U.S.A. Medical, LLC
- Registration Number
- 2025102
- FEI Number
- 3004949275
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1 Brasseler Blvd
- City
- Savannah
- State
- GA
- ZIP
- 31419
- Country
- US
Regulatory Submissions
- 510(k) Number
- K863788
Owner / Operator
- Firm Name
- Brasseler U.S.A. Medical, LLC
- Operator Number
- 9010748
- Address
- 1 Brasseler Blvd
- City
- Savannah
- State
- GA
- Postal Code
- 31419
- Country
- US
- Correspondent
- Carl Mazzolini
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2013-01-07 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2008-04-04 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2005-03-23 |
| Saw, Pneumatically Powered | KFK | Class 1 | General, Plastic Surgery | No | 2015-10-19 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2008-04-04 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2008-04-04 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2008-04-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-11 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 1999-04-28 |
| System, Cement Removal Extraction | LZV | Class 2 | Orthopedic | No | 2025-02-17 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 1994-06-21 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2008-04-04 |
| Blade, Saw, Surgical, Cardiovascular | DWH | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2006-01-06 |
Proprietary Names
BRASSELER BURR, ORTHOPEDIC
Arthrex Large Bone Sagittal Blade
Stryker Total Ankle Reconstruction Blade
BRASSELER BUR, SURGICAL, GENERAL & PLASTIC SURGERY SURGICAL
BRASSELER SAW, PNEUMATICALLY POWERED
BRASSELER Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
BRASSELER WRAP STERILIZATION
BRASSELER LAVAGE, JET
BRASSELER Orthopedic manual surgical instrument
BRASSELER SAW, POWERED AND ACCESSORIES
BRASSELER DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
BRASSELER BLADE, SAW, SURGICAL CARDIOVASCULAR
BRASSELER LAVAGE JET
VersaDriver Pneumatic Osteotome System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device