FDA Registration
Active
🇲🇾 Malaysia
Interseal Alt Shell Impactor Group 3 (83000000)
Reg #: 3012217062
·
FEI: 3012217062
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRAITS ORTHOPAEDICS (MFG) SDN BHD
- Registration Number
- 3012217062
- FEI Number
- 3012217062
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No 2483 Tingkat Perusahaan 4A, Prai Free Industrial Zone
- 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 |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-05-27 |
Proprietary Names
Interseal Alt Shell Impactor Group 3 (83000000)
Odyssey DCF FEM RESECT BLOCK W/WIDE ANT SLOT SZ 4
Odyssey DCF FEM RESECT BLOCK W/WIDE ANT SLOT SZ 1
Odyssey DCF FEM RESECT BLOCK W/WIDE ANT SLOT SZ 2
Profemur Modular Neck
Interseal Alt Shell Impactor Group 1 (81000000)
TRANSCEND® MODULAR LINER (80000020)
PROFEMUR® CEMENTED STEM INSERT FOR CEMENTED STEMS (PRCMSTIN)
TRANSCEND® MODULAR LINER IMPACTOR TIP (80000020)
TRANSCEND® SHELL IMPACTOR TIP GROUP 0(80000000)
TISSUE PROTECTOR SALVATION MIDFOOT NAIL (SMN10012)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)