FDA Registration
Active
🇲🇾 Malaysia
ALTIVATE TM ANATOMIC STRAIGHT TORX DRIVER (804-07-167)
Reg #: 3004889950
·
FEI: 3004889950
·
Expires 2025
Products
1
Proprietary Names
30
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 |
|---|---|---|---|---|---|
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2016-12-15 |
Proprietary Names
ALTIVATE TM ANATOMIC STRAIGHT TORX DRIVER (804-07-167)
3.5mm Hex Driver, Straight, 1/4in Square Locking
ANTERIOR OFFSET CUP IMPACTOR DRIVER 20162012
DRIVER STAR 7 (5202000016)
Driver Star 25 - 2.5 Cann (156016)
Driver Star 15 - 1.5 Cann (156014)
DRIVER STAR #8 CANNULATED (DSDS0008)
DRIVER HEX 2MM STERILE (57S02020)
DRIVER STAR 20 RETAINING (59250090)
DRIVER STAR 10 (5362000110)
CORETRAK HEX DRIVER 3.5MM (EFSR5002)
DRIVER STAR 15 STRAIGHT (58861T15)
Driver Star T8 (D02T8C2N)
DRIVER STAR T8 STERILE (D02T8C2S)
Driver Star 7 - 0.9 Cann (156011)
Driver Star T15 (D02T150N)
INST DRVR STAR 15 FOOT SS MCM (156168)
CLAW II STAR 10 DRIVER (40251100)
DRIVER 1.6MM HEX CANNULATED (DSDS0160)
Driver Star 25 2.5 Cann (156016)
DRIVER STAR #15 CANNULATED (DSDS0015)
DRIVER 2MM HEX CANNULATED (DSDS0200)
COMP SLD DRVR SZ 15 (156018)
Driver Star T25 (D02T250N)
Driver Star T20 (D02T200N)
DRIVER STAR #10 CANNULATED (DSDS0010)
COMP SCR DRVR 2/2.7 (156019)
COMP SLD DRVR SZ 8 (156017)
Driver Star 10 (5362000110)
Screw, Headless Cross 3.5 x 12mm to 60mm (RFS35-12T to RFS35-60T)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)