FDA Registration
Active
🇯🇵 Japan
REUSE SUCTION / IRRCYL BRUSH 7.6DIA 1PC (CS-C2S)
Reg #: 3003782610
·
FEI: 3003782610
·
Expires 2025
Products
1
Proprietary Names
24
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HOYA Corporation PENTAX Lifecare Division
- Registration Number
- 3003782610
- FEI Number
- 3003782610
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 30-2 Okada, Aza-Shimomiyano, Tsukidate
- City
- KURIHARA-SHI Miyagi
- Country
- JP
Owner / Operator
- Firm Name
- HOYA Corporation PENTAX Division
- Operator Number
- 8030235
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- Postal Code
- 07645
- Country
- US
- Correspondent
- Gurvinder Nanda
US Agent
- Business Name
- HOYA CORPORATION PENTAX DIVISION
- Contact Name
- Gurvinder Nanda
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- ZIP
- 07645
- Country
- US
- [email protected]
- Phone
- 201 5712318
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2014-05-13 |
Proprietary Names
REUSE SUCTION / IRRCYL BRUSH 7.6DIA 1PC (CS-C2S)
CLEANING BRUSHES - 10 PER PACK (CS-6021T)
CLEANING BRUSH, TD6.O LN210CM (CS-6021SN)
A/W, S & FWJ CYLINDER CLEANING (CS-C5S)
CLEANING BRUSH, A/W CHANNEL FOR, VSB-343 (CS-3030S)
CLEANING BRUSH TD3,LN250CM FOR 30/40 S (CS-3025S)
CLEANING BRUSH RESUABLE (CS-C9S)
Single Use Channel Cleaning Brush (CS5522A)
CLEANING BRUSH, TD LN300CM (CS-6030SN)
CLEANING BRUSH (CS-6015ST)
CLEANING BRUSH (OF-Z14)
Single Use Channel Cleaning Brush (CS4010A)
Single use Port/ Cylinder Brush (CS-C13A)
Single use Port/ Cylinder Brush (CS-11A)
Single Use Channel Cleaning Brush (CS2022A)
Single use Port/ Cylinder Brush (CS-12A)
CLEANING BRUSH (CS-6002SN)
PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS5530A)
PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS5503A)
Cleaning brushes for endoscope cylinder (CS-C3S)
PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS-C11A)
Cleaning Brushes for Endoscope Channels (CS3010S)
PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS2010A)
PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits(CS3022A)
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device