FDA Registration
Active
🇲🇾 Malaysia
HEADLESS SCREW 3MM X 22MM (D2N30022)
Reg #: 3012217062
·
FEI: 3012217062
·
Expires 2025
Products
1
Proprietary Names
108
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
Regulatory Submissions
- 510(k) Number
- K082320
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-07-21 |
Proprietary Names
HEADLESS SCREW 3MM X 22MM (D2N30022)
HEADED SCREW 3.5MM X 36MM (D1N35036S)
HEADED SCREW 4MM X 12MM (D1N40012S)
HEADLESS SCREW 3MM X 20MM (D2N30020)
HEADED SCREW 4MM X 28MM (D1N40028S)
HEADED SCREW 3.5MM X 50MM (D1N35050S)
HEADED SCREW 4MM X 54MM (D1N40054S)
HEADED SCREW 4MM X 34MM (D1N40034S)
HEADED SCREW 3.5MM X 44MM (D1N35044S)
HEADED SCREW 3.5MM X 58MM (D1N35058S)
HEADED SCREW 3.5MM X 18MM (D1N35018S)
HEADLESS SCREW 3MM X 24MM (D2N30024)
HEADED SCREW 4MM X 60MM (D1N40060S)
HEADED SCREW 4MM X 58MM (D1N40058S)
HEADED SCREW 3.5MM X 32MM (D1N35032S)
HEADED SCREW 3.5MM X 20MM (D1N35020S)
HEADED SCREW 4MM X 10MM (D1N40010S)
HEADLESS SCREW 3MM X 30MM (D2N30030)
D1N25018S HEADED SCREW 2.5MM X 18MM
D1S40054S HEADED SCREW 4MM X [TAB] DART-RIRE COMPRESSION
HEADED SCREW 3.5MM X 56MM (D1N35056S)
HEADED SCREW 3.5MM X 40MM (D1N35040S)
HEADED SCREW 4MM X 18MM (D1N40018S)
HEADED SCREW 3.5MM X 30MM (D1N35030S)
HEADED SCREW 3.5MM X 14MM (D1N35014S)
HEADLESS SCREW 3MM X 32MM (D2N30032)
HEADLESS SCREW 3MM X 26MM (D2N30026)
HEADED SCREW 3.5MM X 16MM (D1N35016S)
HEADED SCREW 4MM X 56MM (D1N40056S)
HEADED SCREW 3.5MM X 60MM (D1N35060S)
D1N20022S HEADED SCREW 2MM X 22MM
D1N25010S HEADED SCREW 2.5MM X 10MM
HEADED SCREW 4MM X 16MM (D1N40016S)
D1N25028S HEADED SCREW 2.5MM X 28MM
138491 HEADED SCREW 4MM X [TAB] DART-RIRE COMPRESSION
D2N25028 HEADLESS SCREW 2.5MM X 28MM
D1N20014S HEADED SCREW 2MM X 14MM
D2N25020 HEADLESS SCREW 2.5MM X 20MM
D1N25026S HEADED SCREW 2.5MM X 26MM
D2N25016 HEADLESS SCREW 2.5MM X 16MM
D1N25016S HEADED SCREW 2.5MM X 16MM
D1N25022S HEADED SCREW 2.5MM X 22MM
HEADED SCREW 4MM X 52MM (D1N40052S)
D1N20020S HEADED SCREW 2MM X 20MM
D1N25036S HEADED SCREW 2.5MM X 36MM
HEADED SCREW 4MM X 20MM (D1N40020S)
HEADLESS SCREW 3MM X 12MM (D2N30012)
D1N25032S HEADED SCREW 2.5MM X 32MM
D2N25014 HEADLESS SCREW 2.5MM X 14MM
HEADED SCREW 4MM X 46MM (D1N40046S)
HEADED SCREW 3.5MM X 24MM (D1N35024S)
D1S40012S HEADED SCREW 4MM X [TAB] DART-RIRE COMPRESSION
HEADED SCREW 4MM X 42MM (D1N40042S)
HEADED SCREW 4MM X 14MM (D1N40014S)
HEADED SCREW 3.5MM X 46MM (D1N35046S)
HEADLESS SCREW 3MM X 36MM (D2N30036)
D2N25030 HEADLESS SCREW 2.5MM X 30MM
D2N25036 HEADLESS SCREW 2.5MM X 36MM
HEADED SCREW 4MM X 22MM (D1N40022S)
HEADLESS SCREW 3MM X 16MM (D2N30016)
HEADED SCREW 4MM X 48MM (D1N40048S)
HEADED SCREW 3.5MM X 28MM (D1N35028S)
HEADED SCREW 3.5MM X 34MM (D1N35034S)
D1N25030S HEADED SCREW 2.5MM X 30MM
HEADLESS SCREW 3MM X 38MM (D2N30038)
HEADED SCREW 4MM X 32MM (D1N40032S)
HEADED SCREW 3.5MM X 10MM (D1N35010S)
HEADLESS SCREW 3MM X 40MM (D2N30040)
HEADED SCREW 3.5MM X 26MM (D1N35026S)
D1N25024S HEADED SCREW 2.5MM X 24MM
D2N25010 HEADLESS SCREW 2.5MM X 10MM
HEADLESS SCREW 3MM X 18MM (D2N30018)
HEADED SCREW 4MM X 24MM (D1N40024S)
HEADED SCREW 3.5MM X 48MM (D1N35048S)
HEADED SCREW 4MM X 38MM (D1N40038S)
D2N25026 HEADLESS SCREW 2.5MM X 26MM
HEADED SCREW 4MM X 44MM (D1N40044S)
HEADED SCREW 4MM X 36MM (D1N40036S)
HEADED SCREW 4MM X 50MM (D1N40050S)
HEADED SCREW 3.5MM X 54MM (D1N35054S)
HEADED SCREW 3.5MM X 52MM (D1N35052S)
HEADED SCREW 3.5MM X 42MM (D1N35042S)
HEADLESS SCREW 3MM X 34MM (D2N30034)
HEADED SCREW 3.5MM X 22MM (D1N35022S)
HEADLESS SCREW 3MM X 28MM (D2N30028)
HEADED SCREW 4MM X 30MM (D1N40030S)
HEADED SCREW 4MM X 40MM (D1N40040S)
HEADLESS SCREW 3MM X 14MM (D2N30014)
HEADED SCREW 4MM X 26MM (D1N40026S)
HEADED SCREW 3.5MM X 38MM (D1N35038S)
D2N25022 HEADLESS SCREW 2.5MM X 22MM
D2N25012 HEADLESS SCREW 2.5MM X 12MM
D1N25020S HEADED SCREW 2.5MM X 20MM
D1N20024S HEADED SCREW 2MM X 24MM
D1N25012S HEADED SCREW 2.5MM X 12MM
HEADED SCREW 3.5MM X 12MM (D1N35012S)
D1N20018S HEADED SCREW 2MM X 18MM
D1N20016S HEADED SCREW 2MM X 16MM
D1N25034S HEADED SCREW 2.5MM X 34MM
138470 HEADED SCREW 4MM X [TAB] DART-RIRE COMPRESSION
D2N25038 HEADLESS SCREW 2.5MM X 38MM
D1N25014S HEADED SCREW 2.5MM X 14MM
D1N20012S HEADED SCREW 2MM X 12MM
D1N20010S HEADED SCREW 2MM X 10MM
D2N25032 HEADLESS SCREW 2.5MM X 32MM
D2N25024 HEADLESS SCREW 2.5MM X 24MM
D2N25034 HEADLESS SCREW 2.5MM X 34MM
D2N25018 HEADLESS SCREW 2.5MM X 18MM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)