FDA Registration
Active
🇹🇷 Türkiye
590 Neo G Adhesive Silicone Longitudinal Arch Support (Sizes S or L)
Reg #: 3009303371
·
FEI: 3009303371
·
Expires 2025
Products
1
Proprietary Names
37
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 |
|---|---|---|---|---|---|
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2011-04-20 |
Proprietary Names
590 Neo G Adhesive Silicone Longitudinal Arch Support (Sizes S or L)
CODE 548 SILICONE TOE CAP
584 Neo G Adhesive Silicone Heel Spur (Sizes S - XL)
CODE 546 SILICONE TOE SEPARATOR
549 Neo G Silicone Forefoot Insole
CODE 589 ADHESIVE SILICONE METATARSAL PAD
CODE 550 SILICONE BUNION SHIELD
548 Neo G Silicone Toe Cap (S or L)
553 Neo G Silicone Toe Crest with Loop (R/L)
543 Neo G Silicone 3/4 Length Insole (Sizes XS - XXL)
CODE 560 SILICONE HAND REHABILITATION BALL
591 Neo G Silicone Full Length Insoles (TechMesh) with Arch Support (Sizes S - XXL)
545 Neo G Silicone Toe Spreaders (Sizes S - L)
550 Neo G Silicone Bunion Shield
CODE 554 SILICONE METATARSAL PAD WITH SEPARATOR
CODE 584 ADHESIVE SILICONE HEEL SPUR
CODE 553 SILICONE TOE CREST WITH LOOP (RIGHT-LEFT)
CODE 542 SILICONE FULL LENGTH INSOLE
CODE 543 SILICONE 3/4 LENGTH INSOLE
544 Neo G Silicone Heel Spur (Sizes S - XL)
CODE 474 PLANTAR FASCITIS SUPPORT WITH SILICONE
589 Neo G Adhesive Silicone Metatarsal Pad (Sizes S or L)
CODE 545 SILICONE TOE SPREADER
542 Neo G Silicone Full Length Insole (Sizes XS - XXL)
CODE 544 SILICONE HEEL SPUR
CODE 541 SILICONE INSOLE WITH ARCH SUPPORT
CODE 582 ADHESIVE SILICONE MEDIAL & LATERAL WEDGE
593 Neo G Silicone 3/4 Length Insoles (TechMesh) (Sizes S - XXL)
CODE 549 SILICONE FOREFOOT INSOLE
CODE 547 SILICONE RING
547 Neo G Silicone Ring (Sizes S - L)
CODE 590 ADHESIVE SILICONE LONGITUDINAL ARCH SUPPORT
CODE 570 SILICONE BREAST PROSTHESIS (PEAR-SYMMETRICAL)
CODE 551 SILICONE METATARSAL PAD WITH RING
582 Neo G Adhesive Silicone Medial & Lateral Wedge (Sizes S - XL)
CODE 552 SILICONE METATARSAL PAD WITH SEPARATOR
594 Neo G Silicone Heel Spurs (TechMesh) (Sizes S - XL)
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