FDA Registration
Active
🇺🇸 United States
Mastoid Round Cutting Burrs
Reg #: 3003790304
·
FEI: 3003790304
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GYRUS ACMI, INC.
- Registration Number
- 3003790304
- FEI Number
- 3003790304
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 800 West Park Drive
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
Proprietary Names
Mastoid Round Cutting Burrs
Viper Mastoid Burrs
Diego Blades
Dermabrader
Stapes Cutting Burrs
Diamond Burrs
Irrigating Blade
Burr
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility