FDA Registration
Active
🇲🇾 Malaysia
4 Cannulated Countersink 211-40-002
Reg #: 3036756245
·
FEI: 3036756245
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRAITS ORTHOPAEDICS (MFG) SDN BHD
- Registration Number
- 3036756245
- FEI Number
- 3036756245
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PMT 10, Lorong Saga Jaya 5,, Taman Perindustrian Saga Jaya,
- City
- Perai Pulau Pinang
- Country
- MY
Owner / Operator
- Firm Name
- Straits Orthopaedics (Mfg) Sdn Bhd
- Operator Number
- 10048319
- Address
- No. 2 Lengkok Teluk Kumbar, Jalan Teluk Kumbar
- City
- Bayan Lepas
- State
- Pulau Pinang
- Postal Code
- 11920
- Country
- MY
- Correspondent
- TH SU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Countersink | HWW | Class 1 | Orthopedic | No | 2019-02-08 |
Proprietary Names
4 Cannulated Countersink 211-40-002
5.5mm Countersink Tiger Large Cannulated Screw System 215-55-002
3 / 4 Cannulated Countersink Tiger Cannulated 211-40-102
Depthsink 8.9 (155980)
Depthsink 3.8mm (155970)
FO Countersink (Cannulated) (MSCK-0000)
COUNTERSINK 4.5MM (D044514N)
Contersink 5.5mm, 2mm K-Wire (D045520N)
Depthsink 4.1mm (155971)
Depthsink 8.9mm (155980)
Depthsink 6mm (155977)
Depthsink 2.3mm (155966)
Depthsink 3.9mm (155975)
Depthsink 6.1mm (155974)
Contersink 6.5mm, 2.4mm K-Wire (D046524N)
Contersink 7.3mm, 2.4mm K-Wire (D047324N)
2mm Arsenal Drill Arsenal 330-27-003
2 / 2.4 Cannulated Countersink Tiger Cannulated 211-24-102
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)