FDA Registration
Active
🇰🇷 South Korea
Guide Block Standard(Left)
Reg #: 3033519208
·
FEI: 3033519208
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDIFIELD MEDICAL CO., LTD.
- Registration Number
- 3033519208
- FEI Number
- 3033519208
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 94-40, Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, 1st floor, Gadong
- City
- Pocheon Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- MEDIFIELD MEDICAL CO., LTD.
- Operator Number
- 10091668
- Address
- 94-40, Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, 1st floor, Gadong
- City
- Pocheon
- State
- Gyeonggi
- Postal Code
- 11154
- Country
- KR
- Correspondent
- yourim Park
US Agent
- Business Name
- Medynus Inc
- Contact Name
- David Daewon
- Address
- 18 Technology Dr Suite 109 Irvine Ca 92618
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 9320847
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-10-28 |
Proprietary Names
Guide Block Standard(Left)
Cortical Drill Guide; Ankle
Guide Block Drill Guide; Radius
Plate Track; 1.3mm
Locking Drill Guide; Radius
Guide Block Narrow(Right)
Guide Block Wide(Right)
Guide Block Narrow(Left)
Drill Bit; 2.7mm
Screw Holder; 3.6mm
Depth Gauge; Green
Depth Gauge; Blue
Driver Shaft; 3.5mm
Driver Shaft; 3mm
Cortical Drill Guide; Radius
Lag Drill Guide; Ankle
Lag Drill Bit; 3.6mm
Guide Block Wide(Left)
Drill Bit; 2mm
Guide Block Standard(Right)
AO Type Handle
Screw Holder; 3mm
Locking Drill Guide; Ankle
Establishment Types
Manufacture Medical Device