FDA Registration
Active
🇺🇸 United States
70890737
Reg #: 3011050570
·
FEI: 3011050570
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Gyrus ACMI, Inc.
- Registration Number
- 3011050570
- FEI Number
- 3011050570
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9600 Louisiana Ave North
- City
- Brooklyn Park
- State
- MN
- ZIP
- 55445
- 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 |
|---|---|---|---|---|---|
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
Proprietary Names
70890737
Slim Line Nasal Pack
70890729
70890752
70890753
70890733
Wide Line Nasal Pack
70890751
70890734
70890742
70890730
70890735
70890755
70890738
70890757
70890728
70890731
70890740
70890750
70140095
70890741
70890739
70890743
70890732
70890756
70890754
Establishment Types
Complaint File Establishment per 21 CFR 820.198