FDA Registration
Active
🇭🇰 Hong Kong
IS4000 ACCESSORY STARTER KIT
Reg #: 3015224777
·
FEI: 3015224777
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Prolinair Asia Limited
- Registration Number
- 3015224777
- FEI Number
- 3015224777
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- DD129 LOT 3304RP, Ping Ha RD
- City
- Ha Tsuen, Yuen Long, N.T.
- Country
- HK
Owner / Operator
- Firm Name
- Intuitive Surgical, Inc.
- Operator Number
- 9028901
- Address
- 1266 Kifer Road, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94086
- Country
- US
- Correspondent
- Mario Lowe
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-02-16 |
Proprietary Names
IS4000 ACCESSORY STARTER KIT
CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2
STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM
CAMERA STARTER KIT,PANASONIC,HD
IS4200 ACCESSORY STARTER KIT
STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM
STARTER KIT,IS3000,HD ENDOSCOPE,12MM
Establishment Types
Export Device to the United States But Perform No Other Operation on Device