BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    GEL ANKLE - WHITE - 10" ADULT - ADD 3" HOOK & LOOP ON BOTTOM , WITH INSTRUCTIONS

    Reg #: 3007392395 · FEI: 3007392395 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    208
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Zeffer Research & Assoc. S. A. de C. V.
    Registration Number
    3007392395
    FEI Number
    3007392395
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calle Cuarzo S/N Manzana 25 Lote 7 y 8, Maneadero
    City
    Ensenada Baja California
    Country
    MX

    Owner / Operator

    Firm Name
    TIBURON MEDICAL ENTERPRISES
    Operator Number
    9040187
    Address
    915 INDUSTRIAL WAY, --
    City
    San Jacinto
    State
    CA
    Postal Code
    92582
    Country
    US
    Correspondent
    JUAN C ORDAZ

    US Agent

    Business Name
    TIBURON MEDICAL ENTERPRISES, INC
    Contact Name
    JUAN ORDAZ
    Address
    915 INDUSTRIAL WAY
    City
    San Jacinto
    State
    CA
    ZIP
    92582
    Country
    US
    Email
    [email protected]
    Phone
    951 6542333

    Products

    Device Name Product Code
    Joint, Ankle, External Brace ITW

    Proprietary Names

    GEL ANKLE - WHITE - 10" ADULT - ADD 3" HOOK & LOOP ON BOTTOM , WITH INSTRUCTIONS Plntr Fscts Lift Lg/Xl FT SMRT AnklSleveBlackTC1501 NYL XXXLg AnklSlvWhte0103 NYL BX M X-Lg AFO PEDIATRICO, MEDIUM LEFT TRIANGULAR BASE Podus Boot Trnbckle, Large Ankle SleeveGrayTC1501 NYL Med AnklSlevBlkTC1501 POL BX W XLg SWEDISH AFO, W-L STRAP PAD, SWEDISH AFO AnkleSleeveBlueTC1501 NYL XLg AnklSleveWhteTC1501 NYL XXXLg AnklSlvWhte0103 NYL BX W X-Lg AFO PEDIATRICO, EXTRA-LARGE LEFT A.R.T.I./KODEL BOOT MULTI-PODUS BOOT COMPLETE, BLACK, STANDARD T-5 DYNAMIC AFO, XL/R TRAINER SHELL w/FOAM REPL LINER FOR PLANT FAS, L Anterior Plantar Fasciitis, Medium CM Ankle Foot Orthosis, Xtra-Large Left AnklSlvWhiteTC1501 NYL BX M Sm Ankle SleeveWhiteTC1501 POL Lg AnklBlckTC1501 POL BX M 2X-Lg PIP Extnesion, Xtra Small SWEDISH AFO, W-R MULTI PODUS BOOT SOLE ONLY,XL GREEN GEL ANKLE-10" AnkleSleeveWhiteTC1501 NYL XLg AnkleSleveBlueTC1501 POL XXXLg Ankle Sleeve NudeTC1501 POL Md CONEJO BED BOOT, COMPLETE NIGHT SPLINT, MEDIUM SWEDISH AFO (UNFINISHED), W-R T-5 DYNAMIC AFO, M/R AnkleSleveBlueTC1501 NYL XXLg Ankle Sleeve NudeTC1501 NYL Sm Ankle SleeveBlackTC1501 POL Sm Ankle Sleeve GrayTC1501 POL Lg Ankle Sleeve BlueTC1501 NYL Sm AnklSlvWhiteTC0103 NYL BX W Sm AFO PEDIATRICO, EXTRA-LARGE RIGHT REPL LINER FOR PLANT FAS, S STD ADJ P. FOOT SPLINT LINER,L AFO PEDIATRICO, MEDIUM RIGHT AnkleSleeveNudeTC1501 NYL XXLg Ankle SleeveWhiteTC1501 POL Sm SWEDISH AFO, M-L PLANTAR FASCIITIS - LARGE CM Ankle Foot Orthosis, Large Left MULTI PODUS BOOT LINER, XL Ankle SleeveBlueTC1501 NYL Med AnklSlvWhite0103 NYL BX W Med AFO PEDIATRICO, LARGE LEFT AnkleSleeveWhiteTC1501 NYL Med AnkleSleeveBlueTC1501 POL XLg CM Ankle Foot Orthosis, Small Right NIGHT SPLINT, SMALL GEL ANKLE - WHITE Podus Boot Liner W/Straps, Standard PLANTAR FASCIITIS - MEDIUM Podus Boot Wide, Xlg CM Ankle Foot Orthosis, Medium Right AnkleSleeveGrayTC1501 NYL XXLg Ankle Sleeve BlueTC1501 POL Sm MULTI PODUS BOOT LINER, S Plantar Fasciitis Lift, Sm/Med Ankle SleeveWhiteTC1501 NYL Sm Ankle SleeveBlueTC1501 POL Lg AnkleSleeveBlackTC1501 NYL Lg AnklSlvBlckTC1501 POL BX M Med AFO Pediatrico, Extra Small Right GEL ANKLE 9" TRAINER DLX ADJ P. FOOT SPLINT, LARGE SWEDISH AFO (UNFINISHED), M-R T-5 DYNAMIC AFO, XL/L Ambulatory Podus Boot, Extra Large Podus Boot Trnbckle, Medium Plntr Fscits Lift S/M FT SMRT PLANTAR FASCIITIS - SMALL MULTI-PODUS BOOT COMPLETE, BLACK, EXTRA-LARGE CHILD AFO, EXT-SMALL LEFT Plantar Fasciitis with Buckle Strap, Medium T-5 DYNAMIC AFO, M/L CHILD AFO, LARGE RIGHT DLX ADJ P. FOOT SPLINT, MEDIUM Ambulatory Podus Boot, Standard Podus Boot Trnbckle, Small WEDGE AnkleSleeveBlackTC1501 NYL XLg AnklSlvBlckTC1501 POL BX M Lg CONEJO BED BOOT, FRAME ONLY NIGHT SPLINT, LARGE CM Ankle Foot Orthosis, Small Left STD ADJ P. FOOT SPLINT, SMALL T-5 DYNAMIC AFO, L/R STD ADJ P. FOOT SPLINT LINER,S Ankle Sleeve NudeTC1501 NYL Lg AnkleSleeveBlackTC1501 POL Lg AnkleSleeveGrayTC1501 POL XXLg Shell for Podus NoSoleNoK, Std CHILD AFO, EXT-SMALL RIGHT AFO PEDIATRICO, SMALL LEFT STD ADJ P. FOOT SPLINT, LARGE Strap, for Child AFO Loop 12" MULTI-PODUS BOOT COMPLETE W/ SIDE STRAPS, BLACK, STANDARD CHILD AFO, SMALL RIGHT SWEDISH AFO, M-R PLANTAR FASCIITIS - X-LARGE CM Ankle Foot Orthosis, Large Right SWEDISH AFO (UNFINISHED), M-L Wide Podus Boot Liner, Xlg DLX ADJ P. FOOT SPLINT LINER,M Ankle Sleeve GrayTC1501 NYL Sm AnklSlvBlckTC1501 POL BX W Lg AnkleSleeveNudeTC1501 POL XXLg Formed Foam Heel Pad STD ADJ P. FOOT SPLINT, MEDIUM REGULAR SHELL w/FOAM SOCK, OPTIONAL, METALCARPAL REPL LINER FOR PLANT FAS, M 10" GEL BAG ONLY REPL LINER FOR PLANT FAS,XL Shell for Podus NoSoleNoK, Xlg CHILD AFO, SMALL LEFT DLX ADJ P. FOOT SPLINT LINER,L AnkleSleveNudeTC1501 NYL XXXLg Ankle SleeveWhieTC1501 POL Med AnkleSleveBlueTC1501 NYL XXXLg Ankle Sleeve NudeTC1501 NYL Md AnkleSleeveBlackTC1501 POL Med Ankle SleeveGrayTC1501 POL XLg AnklSlvWhite0103 NYL BX M Med AnkleSleeveWhiteTC1501 POL XLg AnklSlvgGreyTC0103 POL BX M Sm AnklSlvBlckTC1501 POL BX W Med Ankle SleeveBlueTC1501 NYL Lg AnkleSleveWhiteTC1501 NYL XXLg MULTI PODUS BOOT SOLE ONLY,S AnklSlvWhite0103 NYL BX W Lg AnkleSleveWhiteTC1501 POL XXLg AnklSlvgGryTC0103 POL BX M Med AFO PEDIATRICO, LARGE RIGHT DLX ADJ P. FOOT SPLINT, SMALL MULTI-PODUS BOOT COMPLETE W/ SIDE STRAPS, BLACK, EXTRA-LARGE CHILD AFO, MEDIUM LEFT AnkleSleeveBlackTC1501 NYL Med Ankle SleeveGrayTC1501 NYL XLg AnklSleveBlackTC1501 POL XXXLg AnkleSleeveWhiteTC1501 NYL Lg AnkleSleveBlueTC1501 POL XXLg Ankle Sleeve NudeTC1501 POL Sm AFO Pediatrico, Extra Small Left Plantar Fasciitis with Buckle Strap, Extra-Large CHILD AFO, EXT-LARGE RIGHT Anterior Plantar Fasciitis, Large CM Ankle Foot Orthosis, Xtra-Large Right CHILD AFO, MEDIUM RIGHT AnklSlvgGry0103 POL BX M X-Lg GEL ANKLE - WHITE + HOOK&LOOP SWEDISH AFO (UNFINISHED), W-L T-5 DYNAMIC AFO, S/R REPL LINER&STRAP, CHLD WLKR SM AnklSlvBlckTC1501 POL BX W Sm MULTI PODUS BOOT REPLACE SCREW REPL LINER&STRAP, CHLD WLKR LG AnklSleveWhteTC1501 POL XXXLg AnklSlvgGryTC0103 POL BX M Lg Plantar Fasciitis Lift, Lg/Xlg Ankle Sleeve GrayTC1501 POL Sm Ankle Sleeve NudeTC1501 POL Lg Plantar Fasciitis with Buckle Strap, Small T-5 DYNAMIC AFO, S/L CHILD AFO, LARGE LEFT AnklSlvBlckTC1501 POL BX M Sm ANTI-ROTATION DEVICE T-BAR Plantar Fasciitis with Buckle Strap, Large T-5 DYNAMIC AFO, L/L CHILD AFO, EXT-LARGE LEFT STD ADJ P. FOOT SPLINT LINER,M AnkleSleeve NudeTC1501 NYL XLg AnkleSleeveBlackTC1501 POL XLg AnkleSleeveGrayTC1501POL XXXLg AnklSleeveBlackTC1501 NYL XXLg AnklSlvWhite0103 NYL BX M Lg AnklSlvBlckTC1501 POL BX M XLg AFO PEDIATRICO, SMALL RIGHT Podus Boot Wide, Std CM Ankle Foot Orthosis, Medium Left Foam Pad for Strap, Child AFO Wide Podus Boot Liner, Std DLX ADJ P. FOOT SPLINT LINER,S Podus Boot Liner W/Wtraps, Extra Large Ankle SleeveGrayTC1501 POL Med Ankle SleeveNudeTC1501 POL XLg AnkleSleveGrayTC1501 NYL XXXLg Ankle SleeveBlueTC1501 POL Med CONEJO BOOT, REPLACEMENT LINER AnkleSleveNudeTC1501 POL XXXLg FOAM PAD KIT A.R.T.I. BOOT REPLACE LINER Ankle SleeveBlackTC1501 NYL Sm Ankle Sleeve GrayTC1501 NYL Lg AnklSleeveBlackTC1501 POL XXLg AnkleBlckTC1501 POL BX W 2X-Lg NORCO ANKLE CONTRACTURE BOOT NORCO ANKLE CONTRACTURE BOOT WITH SIDE STRAPS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device