FDA Registration
Active
🇺🇸 United States
LTF-VH
Reg #: 3011050570
·
FEI: 3011050570
·
Expires 2025
Products
1
Proprietary Names
19
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 |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-03-28 |
Proprietary Names
LTF-VH
OTV-S7H-1NA-10E
LTF-160
OTV-S7H-1NA-12Q
OTV-S7H-VA
LTF-VP-S
LTF-S190-5
OTV-S7H-NA-12Q
OTV-S7H-NA
OTV-S7H-1NA
OTV-S7H-N
OTV-S7H-NA-10E
LTF-VP
OTV-S7H-NA-10Q
OTV-S7H-1NA-12E
OTV-S7PROH-HD-12Q
LTF-V3
OTV-S7H-NA-12E
OTV-SP1H-NA-12E
Establishment Types
Complaint File Establishment per 21 CFR 820.198