FDA Registration
Active
🇹🇷 Türkiye
212 GABARDINE ARM SLING
Reg #: 3033436414
·
FEI: 3033436414
·
Expires 2025
Products
1
Proprietary Names
20
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SANAYI VE TICARET LTD STI
- Registration Number
- 3033436414
- FEI Number
- 3033436414
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- K.3, NO:26B HALKALI MERKEZ MAHALLESI SEHIT ISMET CAVUS SOKAK DEREBOYU CADDESI,
- City
- KUCUKCEKMECE Istanbul
- Country
- TR
Owner / Operator
- Firm Name
- VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SA
- Operator Number
- 10091542
- Address
- K.3, NO:26B HALKALI MERKEZ MAHALLESI SEHIT ISMET CAVUS SOKAK DEREBOYU CADDESI,
- City
- KUCUKCEKMECE
- State
- Istanbul
- Postal Code
- 34303
- Country
- TR
- Correspondent
- Recep Bayrak
US Agent
- Business Name
- KAPLAN DISTRIBUTION LLC.
- Contact Name
- MEHMED UGUR
- Address
- 828 N Olden Ave Suite #4
- City
- Trenton
- State
- NJ
- ZIP
- 08638
- Country
- US
- [email protected]
- Phone
- 908 3138133
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2024-10-15 |
Proprietary Names
212 GABARDINE ARM SLING
206 ARM SLING (45-60 DEGREES)
304 NEOPRENE EPICONDYLITIS BANDAGE
VK-204 VELPAU BANDAGE (XXXS - XXS - XS)
207-UNV STANDART SHOULDER SUPPORT
202 ARM SLING (PERFORATED)
1024 RIGHT ELBOW ROM ORTHOSIS
5501 CCL1 (18-21mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH A STRAP
5600 CCL2 (23-32mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH SILICONE BAND
304-S EPICONDYLITIS BANDAGE WITH SILICONE PAD
304-J EPICONDYLITIS BANDAGE WITH GEL PAD
VK-203 ARM SLING (XXXS - XXS - XS)
204 VELPAU BANDAGE
214 VELPAU BANDAGE ULTRA
5500 CCL1 (18-21mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH SILICONE BAND
201 ARM SLING SIMPLE STANDARD
5601 CCL2 (23-32mmHg) LYMPH EDEMA SLEEVE FINGER TO SHOULDER WITH A STRAP
5834 FITTECH EPICONDYLITIS BANDAGE (S - M) 1 - (L - XL - XXL) 2
205 ARM SLING (30 DEGREES)
203 ARM SLING (Sizes S - XXL)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)