BEUDAMED
    FDA Registration Active 🇺🇸 United States

    6895-1364 - ADANTE FRICTION PAD

    Reg #: 2921578 · FEI: 2921578 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    196
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Registration Number
    2921578
    FEI Number
    2921578
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    30031 AHERN AVE
    City
    UNION CITY
    State
    CA
    ZIP
    94587
    Country
    US

    Owner / Operator

    Firm Name
    Mizuho Orthopedic Systems, Inc.
    Operator Number
    2921578
    Address
    30031 Ahern Avenue, --
    City
    Union City
    State
    CA
    Postal Code
    94587
    Country
    US
    Correspondent
    Mark - DeSilets

    Products

    Device Name Product Code
    Support, Patient Position CCX

    Proprietary Names

    6895-1364 - ADANTE FRICTION PAD 10715 - LATERAL COMFORT POSITIONER 10813 - CHEST ROLL W/FLAT BOTTOM, 20" X 4" X 3" 5322PV-1 - PKIT, RWF, LPV CUSHION, ARM CRADLES 1/EA 6950-04 - WEDGE, SPINAL, TEMPUR-MED 10201 - HEAD RING, GEL, PED, CLOSED, 3.5" DIA 1937GT3D-M - GT3D PRONE PILLOW DUAL SAFESLOT MD EA 3368R - Perineal Post, Pediatric, Refurbished 5809-1 - PKIT, 7IN GT PLW SG COVER ARM PAD, 1/EA 5875-7010 - PAD, FOOT END, MONTREAL, 20X27X2 6844PV-1 - PKIT, PRONEVIEW, INSITE, SINGLE 6855DPAA-1 - PKIT HANA DISTRACTION PAD AATHA KIT EA 946PV-1 - PKIT, AF, APV, SI 1937GT3D-L - GT3D PRONE PILLOW DUAL SAFESLOT LG EA 5808PV-2 - Pkit, STS Trios, LPV, SG Arm Pad 5834PV-1 - PKIT, STS, APV PILLOW, SG COVER, 1/EA 6747-1 - PKIT, INSITE, GENTLE TOUCH (1/EA) 6988-359 - ProAxis Tempur-Pedic Hip/Thigh Pad Set 946-1 - PKIT, AF, 7" GENTLE TOUCH PILLOW, SI 1902 - POSITIONER, HEAD 5326-1 - PKIT, RWF, 7" GENTLETOUCH PILLOW, 1/EA 5808DCP-1 - PKIT SST 7"GT PILLOW SG ARM COVER PAD 5931 - NervPro SYSTEM ULNAR PROTECTIVE PAD, 1PR 6977-7512 - HOSE SET, ADVANCE CONTROL PADS, 12/CASE 6983PV-1 - PKIT, AXIS, LPV, SG, ARM CRADLES, 1/EA 10811 - CHEST ROLL W/FLAT BOTTOM, 12" X 4" X 3" 10814 - CHEST ROLL W/FLAT BOTTOM, 12" X 6" X 4" 5322PV-12 - PKIT RWF-LPV APV CUSHION ARM CRADLE 2/EA 6950-05 - BLOCK, CRADLE, TEMPUR-MED 6983 - PKIT, AXIS W/O ACP TUBE (6CS) 5260-4 - INFLATABLE CUFF/STRAP ASSEMBLY 5328 - PKIT, RWF, 5IN GT PILLOW, 6/CS 6946 - PILLOW, MODULAR TABLE STANDARD SLING 6980PV-1 - PKIT ATS LPV W/ACP TUBING EACH 1922 - DONUT, POSTION, 7" FOAM BLUE, 24/CASE 5802-1 - PKIT, SST SG CVR ARM PAD W/O PILLOW 1/EA 5819 - PKIT, INDIV W/SHEARGARD, SST-3000 6/CS 6854AA-1 - PKIT HANA SUPINE, NO HEAD, NO BOOT EA 6982PV-2 - PKIT, AXIS, LPV, SG, W/TUBING (3/CS) 6988A-PV - PKIT PROAXIS LPV SG HIP ARM 6/CS 1916L - TLC ABDUCTION PILLOW, LARGE 1937ADZ - PILLOW, GENTLETOUCH 6 INCH RT, 12/CS 5808PV - Pkit, STS Trios, LPV, SG Arm Pad, 6/CS 5996-35 - HOSE SET, ADVANCE CONTROL PADS 6984PV - PKIT, SST BI-LAT LPV W/O ACP, 6/CS 7887PV-1 - PKIT LEVO, PRONEVIEW, SG, ARM 1921 - HEADREST, 9" DONUT, 24/CASE 5802 - PKIT, SST SG CVR ARM PAD W/O PILLOW 6/CS 5809PV-1 - PKIT, AST, LPV PILLOW, SG COVER, 1/EA 6982PV-1 - PKIT, AXIS, LPV, SG, W/TUBING 6988A-PCS-1 - PKIT PROAXIS ARM CRADLE CHEST PAD 1916XS - TLC ABDUCTION PILLOW, EXTRA SMALL 5371-40 - SHORT PAD FOR ARTHROSCOPIC LEG HOLDER 6982-2 - PKIT, AXIS, 5 IN. GT, SG, W/TUBING (3/CS 6988A-GT-1 - PKIT, GT, PROAXIS, 1/EA 10603 - UNI PATIENT POSITIONERS, LG 14X4-1/2X2-1/4 1948DZ - PILLOW, GENTLETOUCH, 4 INCH PEDI, 12/CS 5322 - PKIT, RWF, 7" GT PILLOW, ARM CRADLES 6/CS 6855D-6 - PKIT HANA HIP AATHA, ARTHRO, TRAUMA 6/CS 6950-01 - BLOCK, KNEE, A, TEMPUR-MED 10815 - CHEST ROLL, FLAT BOTTOM, 16 X 6 5322PV-2 - PKIT, RWF, LPV CUSHION, ARM CRADLES 3/CS 5808-1 - Pkit, STS Trios, GT, SG, Arm Pad, EA 6950-06 - PAD, RECTANGLE, TEMPUR-MED 6983-1 - PKIT, AXIS W/O ACP TUBE (SINGLE) 10620 - DOME POSITIONER, 14" X 6" X 3" 3340 - INFANT CAST TABLE 5322-1 - PKIT, RWF,7" GT PILLOW, ARM CRADLES 1/EA 6855DP-1 - PKIT HANA DISTRACTION PAD W/STRAP EACH 6950-02 - BLOCK, KNEE, B, TEMPUR-MED 1927DZ - PILLOW, HEADREST 7 INCH RT, 12/CS 1937SDZ - PILLOW, GENTLETOUCH 5 INCH RT, 12/CS 5819PV - PKITS, AST, APV PILLOW, SG COVER 6/CS 6854NH-1 - PKIT HANA SUPINE, W/ BOOT, NO HEAD EA 6988A-PV-1-ACP - PKIT PROAXIS LPV ACP 1902-20 - HEADREST, SUPINE/LATERAL, 20/CASE 1937 - PILLOW, GENTLETOUCH, 7 INCH RT 5326PV - PKIT, RWF, APV CUSHION, 6/CS 5808DCPPV - PKIT SST APV PILLOW SG COVER ARM PAD 6/C 5932 - NervPro SYSTEM ULNAR PROTECTIVE PAD, 6CS 6984 - PATIENT KIT SST BI-LAT 5IN GT W/O ACP 6/ 1912 - TLC POSITIONER ANKLETS, PAIR 1937A - PILLOW, GENTLETOUCH 6 INCH RT 5808DCPPV-1 - PKIT SST APV PILLOW SG COVER ARM PAD 5996-12 - HOSE SET, ADVANCE CONTROL PADS, 12/CASE 6984-1 - PATIENT KIT SST BI-LAT 5IN GT W/O ACP 1/ 10600 - UNIVERSAL PATIENT POSITIONER, SM-LONG 1941S - PILLOW, GENTLETOUCH 5 INCH LT 5823-12 - FOAM ARM CRADLE, 1 PAIR 6855-1 - Pkit, Hana and ProFx 1/CS 7887GT-1 - PKIT LEVO PLATFORM, 7 IN GT, SG, ARM 1937GT3DZ-L - GT3D PRONE PILLOW DUAL SAFESLOT LG 12CS 5809 - PKIT, 7IN GT PLW SG COVER ARM PAD, 6/CS 5875-7008 - PAD, HEAD END, MONTREAL, 20X31X2 6844PV - PKIT, PRONEVIEW, INSITE, 6/CS 6855DP-5 - PKIT HANA DISTRACTION PAD W/STRAP 5/CS 6988A-GT - PKIT, GT, PROAXIS, 6/CS 946PV - PKIT, AF, APV, 3/CS 1916M - TLC ABDUCTION PILLOW, MEDIUM 1937DZ - PILLOW, GENTLETOUCH 7 INCH RT, 12/CS 5808PV-1 - Pkit, STS Trios, LPV, SG Arm Pad, EA 5834PV - PKIT, STS, APV PILLOW, SG COVER, 6/CS 6747 - PKIT, INSITE, GENTLE TOUCH (6/CS) 6984PV-1 - PKIT, SST BI-LAT LPV W/O ACP, 1/EA 946 - PKIT, AF, 7" GENTLE TOUCH PILLOW, 3/CS 10816 - CHEST ROLL, FLAT BOTTOM, 20" X 6" X 4" 5326 - PKIT, RWF, 7" GENTLETOUCH PILLOW, 6/CS 5808DCP - PKIT SST 7"GT PILLOW SG COVER ARM PAD 6/C 6977-750 - HOSE SET, ADVANCE CONTROL PADS 6983PV - PKIT, AXIS, LPV, SG, ARM CRADLES, 6/CS 10203 - CLOSED GEL HEAD RING, ADULT 1937GT3D-S - GT3D PRONE PILLOW DUAL SAFESLOT SM EA 5022 - SINGLE LOOP LEG PREP 5895-7133 - PAD, MAIN TABLE, 5895 MAX. ACCESS LAT 6851-1 - Pkit, Hana & ProFx, W/Boot Liner 6855DPB-1 - PKIT HANA DISTRACTION PAD BASIC TRC EA 946S-1 - PKIT, AF, 5" GENTLE TOUCH PILLOW, SI 1927 - PILLOW, HEADREST 7 INCH RT 1937S - PILLOW, GENTLETOUCH, 5 INCH RT 5808 - Pkit, STS Trios, GT, SG, Arm Pad, 6/CS 5819-1 - PKIT, INDIV W/SHEARGARD, SST-3000 (1) 6854AA-6 - PKIT HANA SUPINE, NO HEAD, NO BOOT 6/CS 6988A-PV-1 - PKIT PROAXIS LPV SG HIP ARM 1916XL - TLC ABDUCTION PILLOW, EXTRA LARGE 5352-1 - PKIT, RWF, NO PILLOW, W/ARM CRADLES 1/EA 6982-1 - PKIT, AXIS, 5 IN. GT, SG, W/TUBING 5060-3 - 2" BLOCK ONLY FOR WEHBE PREP ASSIST 5326PV-1 - PKIT, RWF, APV CUSHION, 1/EA 5914-1 - Pkit, SST, 7" GT Pillow, Arm Pad, Hip 6855L-1 - PKIT HANA LATERAL SET WITH BOOT EA 6980-1 - PKIT, CARE KIT W/TUBING, 1/EA 10205 - HEAD RING, GEL, PED, OPEN, 3.5" DIAM 1937GT3DZ-S - GT3D PRONE PILLOW DUAL SAFESLOT SM 12CS 5060 - WEHBE EXTREMITY PREP ASSIST 5896 - PKIT, LATERAL TOP 6/CASE 6855DPB-5 - PKIT HANA DISTRACTION PAD BASIC TRC 5/CS CT-356509063 - ROLL, AUXILIARY CHEST, 4 DIA X 11 L 5065 - FOAM, POSITIONER, WELL-LEG 5328-1 - PKIT, RWF, 5IN GT PILLOW, 1/EA 6855L-6 - PKIT HANA LATERAL SET WITH BOOT 6/CS 6980PV - PKIT ATS LPV W/ ACP TUBING (6/CS) 6895FP-5 - ADANTE FRICTION PAD (5) 10202 - HEAD RING, GEL, ADOL, CLOSED, 5.5" DIAM 1937GT3DZ-M - GT3D PRONE PILLOW DUAL SAFESLOT MD 12CS 3390 - ADJUSTABLE LEG REST 5880-80 - LEG WEDGE FOAM PAD (PER PAIR) 6851 - Hana & ProFx Pkit w/boot liner, 6/Cs 6855DPAA-5 - PKIT HANA DISTRACTION PAD AATHA KIT 5/CS 946S - PKIT, AF, 5" GENTLE TOUCH PILLOW, 3/Cs 10206 - HEAD RING, GEL, ADOL, OPEN, 5.5" DIAM 5060-1 - TOP BLOCK ONLY FOR WHBE PREP ASSIST 5896-1 - PKIT, LATERAL TOP, SINGLE 6855DPHA-1 - PKIT HANA DISTRACTION PAD HIP ARTHR EA 10602 - UNI PATIENT POSITIONER, MED 10X4-1/2X2-1/4 1948 - PILLOW, GENTLETOUCH, 4 INCH PEDI 10207 - HEAD RING, GEL, ADULT, OPEN, 8" DIAM 5261 - PICKET FENCE LEG PREP HOLDER 5060-2 - 3" BLOCK ONLY FOR WEHBE PREP ASSIST 5834-1 - PKIT, STS, 7" GT PILLOW, SG COVER 6855D-1 - PKIT HANA HIP AATHA, ARTHRO, TRAUMA EA 5914 - Pkit, SST, 7" GT Pillow, Arm Pad, Hip Thigh Cover, 6/Cs 6950 - Positioning Pad Set Tempur (6 pc) 6855DPHA-5 - PKIT HANA DISTRACTION PAD HIP ARTHR 5/CS 6980 - PKIT, CARE KIT W/TUBING, 6/CS 1916S - TLC ABDUCTION PILLOW, SMALL 10402 - HEEL CUPS (SET OF 2) 5260-7 - INFLATABLE MITT ASSY 5352 - PKIT, RWF, NO PILLOW, W/ARM CRADLES 6/CS 1927S - PILLOW, HEADREST, 4 INCH RT 1941 - PILLOW, GENTLETOUCH 7 INCH LT 6982 - PKIT, AXIS, 5IN GT, SG W/TUBING, 6/CS 5819PV-1 - PKIT, AST, PRONEVIEW, SG COVER 6854NH-6 - PKIT HANA SUPINE, W/ BOOT, NO HEAD 6/CS 6988A-PV-ACP - PKIT PROAXIS LPV ACP 6/CS 10701 - FOUR POSTER FRAME PADS (SET OF 4) 10812 - CHEST ROLL W/FLAT BOTTOM, 16" X 4" X 3" 3341 - CHILDS CONVERSION KIT 5322PV - PKIT, RWF, LPV CUSHION, ARM CRADLES 6/CS 6950-03 - ROLL, BASIC, TEMPUR-MED 1917 - TLC CRADLE BOOT 5371-50 - STRAIGHT LATERAL PAD 5809PV - PKIT, AST, LPV PILLOW, SG COVER, 6/CS 6982PV - PKIT, AXIS, LPV, SG, W/TUBING, 6/CS 6988A-PCS - PKIT PROAXIS ARM CRADLE CHEST PAD 6/CS 10404 - HEEL PROTECTORS, SET OF 2 1927SDZ - PILLOW, HEADREST 4 INCH RT, 12/CS 1941DZ - PILLOW, GENTLETOUCH 7 INCH LT, 12/CS 5823-10 - FOAM, ARM CRADLE, 6 PR / CS 6855 - Pkit, Hana and ProFx 6/CS 7887GT - PKIT LEVO PLATFORM, 7 IN GT, SG, ARM 6/CS 10601 - UNIVERSAL PATIENT POSITIONER, SM-REG 1941SDZ - PILLOW, GENTLETOUCH 5 INCH LT, 12/CS 5834 - PKIT, STS, 7" GT PILLOW, SG COVER, 6/CS 6855-3 - Pkit, Hana & ProFx, 3/CS 6947 - PILLOW, QUEEN, SLING, MODULAR TABLE 7887PV - PKIT LEVO, PRONEVIEW, SG, ARM 6/CS

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device