FDA Registration
Active
🇲🇾 Malaysia
One Step Drill Bit 2.2 x 12mm Cannulated (94058573, DHVS0022)
Reg #: 3004889950
·
FEI: 3004889950
·
Expires 2025
Products
1
Proprietary Names
20
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Straits Orthopaedics (MFG) Sdn Bhd
- Registration Number
- 3004889950
- FEI Number
- 3004889950
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar
- City
- Bayan Lepas 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 |
|---|---|---|---|---|---|
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2018-03-05 |
Proprietary Names
One Step Drill Bit 2.2 x 12mm Cannulated (94058573, DHVS0022)
EVOLUTION® FEMORAL PEG DRILL (E1000301)
ADVANCE® DRILL BIT 1/8 IN W/ QUICK DISCONNECT (K0001005)
Procotyl® Prime Liner Extraction Drill (P3LEXTDR)
PRIME LINER EXTRACTION DRILL (P3LEXTDR)
One Step Drill Bit 2.2 x 22mm Cannulated (94058574, DHVS0L22)
EVOLUTION® 1/8 IN DRILL BIT W/ STOP & QUICK DISCONNECT (E1000201)
Prime Flex Drill Bit 4 x 20mm ( P3FDB420
Procoty® Prime Flex Drill Bit 4 x 40mm (P3FDB440)
ONE STEP DRILL BIT +22MM (DHVS0L24)
Drill Bit 3 - 1.4 Cann (156006)
ADVANCE® DRILL BIT 1/8INX 100m W/ QUICK DISCONNECT (K0001015)
Drill Bit 1.7 - 0.9 Cann (155999)
ONE STEP DRILL BIT +12MM (DHVS0024)
EVOLUTION® 3/8 IN FULLY FLUTED DRILL W/ QUICK DISCONNECT (E5001002)
Drill Bit 5.3 - 2.5 Cann (156010)
Procotyl® Prime Flex Drill Bit 4 x 20mm (P3FDB420)
ODYSSEY® 1/8 IN DRILL BIT W/ STOP (K0001017)
Drill Bit 3.3 - 1.5 Cann (156007)
Inst Cann Drl 3.5mm (156786)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)