FDA Registration
Active
🇺🇸 United States
CONDUCTOR (CONDUCT OR)
Reg #: 2518897
·
FEI: 1000080301
·
Expires 2025
Products
1
Proprietary Names
57
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PENTAX of America, Inc.
- Registration Number
- 2518897
- FEI Number
- 1000080301
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3 Paragon Drive
- City
- MONTVALE
- State
- NJ
- ZIP
- 07645
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2017-10-28 |
Proprietary Names
CONDUCTOR (CONDUCT OR)
VESA MOUNTING ADAPTOR (FLP-0002-17C)
NDS CONDUCTOR G2 BASE UNIT (NDS-CONDOR-BASE)
NDS 21 ENDOVUE MONITOR (NDS90K0061)
XEROX NETWORK LASER PRINTER (74258)
NDS 24" LED MONITOR (NDS24LED)
FILMPACK UPC-21L 4PACKS X 50, 4RIBBONS (74187)
POWER SUPPLY - NDS 32" SPLIT SCREEN MON. (M34021)
PRINTER, COLOR (9264C)
SONY A6 COLOR VIDEO PRINTER 400DPI (UP-21MD)
ZWIRE G2 RADIANCE ULTRA 27 PAIR (NDS90Z0156)
DEMO CASE FOR SCOPE, PROCESSOR & MONITOR (001-007V)
RADIANCE 24" G2 W/SINGLE FIBER (NDS90R0064)
ZEROWIRE G2 ACCESSORY KIT SINGLE FOR 32" (NDS90Z0179)
NDS 21" ENDOVUE DISPLAY (NDS90K0019)
POWER SUPPLY - NDS 23" AND 32" MONITOR (34019)
FILM PACK 50 PRINTS RIBBON 21/20MD 4PC (UPC-21L)
27" RADIANCE ULTRA MONITOR (NDS90X0660)
SONY UP-25MD COLOR VIDEO PRINTER (UP-25MD)
PAPER AND RIBBON KIT (1111-1605)
MONITOR 27" DELL PC (72067)
DEMO CASE FOR SCOPE, PROCESSOR & MONITOR (001-007P)
HEAVY DUTY MONITOR POLE STAND (PE-0001-60)
NDS 19IN RADIANCE HD MONITOR MED GRADE (72064)
ZWIRE G2 RADIANCE ULTRA 27 SINGLE (NDS90Z0157)
NDS 32" LED DISPLAY, W/O FIBER (NDS90X0619)
FILM PACK 100 PRINTS RIBBON 55MD 2PC (UPC-55)
NDS RADIANCE ULTRA 32" ANALOG MONITOR (NDS90R0107)
RADIANCE 55" G2 LED, W/SINGLE FIBER (NDS90R0069)
ZEROWIRE G2 PAIR RX & TX (NDS90T2070)
UP-X898MD B&W VIDEO PRINTER (UP-X898MD)
NATIONAL DISPLAY 26" RADIANCE HD LED MON (NDS26LED)
FILM PACK B&W 240 PRINTS 897MD 10PC (UPP-110HG)
POWER SUPPLY - NDS 26" LED MONITOR (34015)
FILM PACK 200 PRINTS RIBBON 51MDU/D50 (UPC-510)
PRINTER, COLOR HP (7264C)
TALL MONITOR POLE STAND (FLP-0001-70-VHRS)
24" LCD MONITOR HD (MONITOR ST)
DEMO CASE FOR SCOPE, PROCESSOR & MONITOR (001-007S)
NDS CONDUCTOR VIDEO SWITCHING PACKAGE (KBMNDS-CONDOR)
STANDARD MONITOR POLE STAND (FLP-0001-93)
22" DELL LCD MONITOR (72066)
NDS 24" ENDOVUE LED MONITOR (NDS24ENDO)
DEMO CASE FOR POLE STAND (001-007S-P)
DEMO CASE FOR POLE STAND (001-007S-N)
VERSA MONITOR (PM-V10c19)
42" RADIANCE G2 LED WITH SINGLE FIBER (NDS90R0070)
ZEROWIRE G2 ACCESSORY KIT PAIR FOR 32" (NDS90Z0178)
NDS 24" ENDOVUE MONITOR (NDS90X0669)
NDS 24" ENDOVUE MONITOR (NDS90X0711)
55" 4K MEDICAL MONITOR (FSNC5501DV)
32" HD MEDICAL MONITOR (FSNL3202D)
26" HD MEDICAL MONITOR (FSNP2604D)
NDA 91in Radiance HD Monitor Med Grade(NDA90R0056)
NDS 24" ENDOVUE MONITOR (NDS90X0699)
PRINTER HP 6230 (E3E03A#B1H)
PRINTER HP 6230 (1111-2098)
Establishment Types
Complaint File Establishment per 21 CFR 820.198