FDA Registration
Active
🇹🇷 Türkiye
CODE 859 ELBOW ROM ORTHOSIS
Reg #: 3009303371
·
FEI: 3009303371
·
Expires 2025
Products
1
Proprietary Names
54
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Variteks Ortopedi Sanayi A.S.
- Registration Number
- 3009303371
- FEI Number
- 3009303371
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ferhatpasa Sb Mah. Menekse Sk., Variteks Blok No:3 Ic Kapi No:Z1
- City
- Catalca Istanbul
- Country
- TR
Owner / Operator
- Firm Name
- Variteks Ortopedi Sanayi A.S.
- Operator Number
- 10036107
- Address
- Ferhatpasa Sb Mah. Menekse Sk., Variteks Blok No:3 Ic Kapi No:Z1
- City
- ?stanbul
- State
- TR-NOTA
- Postal Code
- 34540
- Country
- TR
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2011-04-20 |
Proprietary Names
CODE 859 ELBOW ROM ORTHOSIS
859 Neo G Post Operative elbow Brace
CODE 301 WRIST BRACE SPLINT
CODE 309 FLEXI WRIST BRACE SPLINT
CODE 458 KNITTED ELBOW SUPPORT (WITH SILICONE)
CODE 880 THUMB BRACE
CODE 306 WRIST SPLINT WITH THUMB GRIP
CODE 160 TX EPICONDYLITIS BANDAGE
350 Neo G Hand Rehabilitation Fist Shaped
CODE 307 ELASTIC WRIST BRACE SPLINT
165 Neo G RX Wrist Brace (R/L) (Sizes S - L)
CODE 882 WRIST SUPPORT
CODE 721 ELBOW SUPPORT
309 Neo G Easy - Fit Wrist Brace (S - L)
CODE 881 WRIST BAND
CODE 311 STATIC WRIST BRACE SPLINT
CODE 460 KNITTED SHOULDER SUPPORT
721 Neo G Airflow Elbow Support (Sizes S - XL)
458 Neo G Airflow Plus Elbow Support with Silicone (Sizes S - XL)
CODE 883 EPICONDYLITIS BANDAGE
CODE 722 WRIST & THUMB SUPPORT
CODE 825 WRIST BRACE SPLINT
881 Neo G Wrist Band
CODE 355 HAND REHABILITATION DEVICE
899 Neo G Elbow Support
880 Neo G Thumb Brace
CODE 829 TENNIS ELBOW SUPPORT
CODE 335 FROG SPLINT
CODE 305 THUMB GRIP
CODE 336 RINGSPLINT FINGER SPLINT
CODE 849 ELBOW SUPPORT WITH SILICONE
CODE 350 HAND REHABILITATION KIT
882 Neo G Wrist Support (Kids Size Available)
722 Neo G Airflow Wrist & Thumb Support (Sizes S - L)
CODE 332 CURVED FINGER SPLINT
CODE 879 WRIST BRACE SPLINT
CODE 760 EPICONDYLITIS BANDAGE
878 Neo G Easy - Fit Thumb Brace
CODE 165 TX WRIST BRACE SPLINT
560 Neo G Hand Rehab Therapy Ball - (3 Resistance levels: Red = Hard , Blue = Medium, Green = Soft )
CODE 319 FLEXI WRIST SPLINT WITH THUMP GRIP
CODE 331 BASEBALL SPLINT
336 Neo G Easy-Fit Finger Splint (Sizes S - XL)
996 Neo G Stabilized Wrist & Thumb Brace (R/L)
CODE 308 SLEEPING WRIST BRACE
CODE 334 FINGER COT
895 Neo G Stabilized Wrist Brace (R/L) (Kids Size Available)
CODE 333 FINGER PROTECTOR
CODE 560 SILICONE HAND REHABILITATION BALL
396 Neo G Comfort/Relief Arthritis Gloves
Code 756 Sports Wrist Support
Code 753 Sports Elbow Support
Code 753 Neo G Sports Elbow Support
Code 756 Neo G Sports Wrist Support
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device