BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DRAWER, DEEP FOR PREC. CART (M80197)

    Reg #: 2518897 · FEI: 1000080301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    50
    Establishment Types
    3
    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
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN

    Proprietary Names

    DRAWER, DEEP FOR PREC. CART (M80197) UTILITY BASKET (RS-0001-24) DUAL SCOPE HOLDER FOR 80247 (80254) FLAT PNL MON ARM SET-COMPACT CART 80225 (80230) MOUNTING BRACKET FOR NDS 32IN MONITOR (80240) DESKTOP STND/NDS RADIANCE 26" HD MONITOR (80246) POLE STAND PREC.FLAT PANEL MONITOR (80232) TRAY 30.4 CM X 40.6 CM FOR 2"/5 CM POST (RS-0018-03) CART, STROBE HUI (9272) ECONOMY CART (80226) SINGLE GAS BOTTLE HOLDER FOR 80247 (80251) HANDLE FOR 2"/5 CM POST (RS-0004-18) DOUBLE GAS BOTTLE HOLDER FOR 80247 (80253) DESKTOP STAND FOR NDS 19/23IN MONITOR (80236) ENDOSCOPIC HOLDER (7174-8301-KIT) DEMO CASE FOR LARGE CARTS - 80247 (001-007C-N) DEMO CASE FOR SMALL CARTS - 80242 (001-007C) MONITOR ARM MOUNTING KIT (80228) WALL MOUNT FOR NDS 42IN MONITOR (80239) DESKTOP STAND FOR NDS 32IN MONITOR (80238) DUAL SCOPE HOLDER TYPE II FOR PREC. CART (M80200) CART, STROBE HUI 230V (9272E) PREC. TRAVEL CART W/FLAT MONITOR ARM H50 (80231) PRECISION FLAT PANEL WALL MOUNT SYSTEM C (80217) PORTABLE SWALLOWING CART (7273) PREC. COMPACT CART H37.5XW24XD (80225) PRECISION TRAVEL CART H37.5 X W43 X D24. (80182) PREC. STANDARD CART FLAT PNL MON. MOUNT H (80233) PATCH PANEL FOR 80247 (80259) MONITOR MOUNT FOR 80247 (80249) TALL CART HUI (80233-2) COMPACT CART W/ ARM SYS. FOR FLAT PANEL (80242) STANDARD CART (80247) SCOPE HOLDER SINGLE (80201) COMPACT CART HUI (80225-2) LED Task Light (END-0002-03) 1600VA Isolation Transformer (M80201) Cart Bin (WM-0001-23) Dual CO2 Gas Bottle Holder (M80194) Slide Out Scope Bin Shelf with Handle (END-0003-03) Vertical CPU Channel Mount (WM-0007-428) Flip Down Keyboard Tray (END-0002-02) Single CO2 Gas Bottle Holder (M80193) SLIM CART (802CP) SLIM CART (820CP) ENDOSCOPIC TROLLEY (PT-V10C) Stor-Locx With Key Lock (RST-0007-86) Gas Cylinder Mount (WM-0009-88) Monitor Mount with 19" Riser (FLP-0008-78) Endoscopy Cart (PEN-003-06)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device