BEUDAMED
    FDA Registration Active 🇺🇸 United States

    550536 S-ROM SLEEVE PRX ZTT 20F-LRG

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    97
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    Country
    US

    Regulatory Submissions

    PMA Number
    P070026

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented MRA

    Proprietary Names

    550536 S-ROM SLEEVE PRX ZTT 20F-LRG 121722066 PINNACLE SECTOR II CUP 66MM 550514 S-ROM SLEEVE PRX ZTT 16D-LRG 523394 S-ROM STM STD 42 NK 20X15X165 563022N S-ROMSTMLG36+21CR8L 22X17X230N 523293 S-ROM STM STD 30 NK 18X13X160 526514N S-ROM STM LG 36NK 14X09X205N 550530 S-ROM SLEEVE PRX ZTT 18F-XXL 550520 S-ROM SLEEVE PRX ZTT 16F-XXL 550505 S-ROM SLEEVE PRX ZTT 14F-SML 521483 S-ROM SLEEVE PRX ZTT 18B-SML 526518L S-ROM STM LG 36NK 18X13X215L 550573 S-ROM SLEEVE PRX ZTT 12D-LRG 550502 S-ROM SLEEVE PRX ZTT 14B-LRG 563042L S-ROMSTMXLG36+21CR8L22X17X275L 550572 S-ROM SLEEVE PRX ZTT 12D-SM 526680 S-ROM STM STD36+21CR 20X15X165 550571 S-ROM SLEEVE PRX ZTT 12B-LARG 523207 S-ROM STM STD 30 NK 12X07X115 550525 S-ROM SLEEVE PRX ZTT 18F-SML 526522N S-ROM STM LG 36NK 22X17X230N 563042R S-ROMSTMXLG36+21CR8L22X17X275R 121722054 PINNACLE SECTOR II CUP 54MM 563036L S-ROMSTMXLG36+21CR4L16X11X240L 550533 S-ROM SLEEVE PRX ZTT 20D-SML 526676 S-ROM STM STD36+21CR 16X11X150 563058L S-ROM STMXXL36+21+8L18X13X315L 550504 S-ROM SLEEVE PRX ZTT 14D-LRG 521463 S-ROM SLEEVE PRX ZTT 16B-SML 526514L S-ROM STM LG 36NK 14X09X205L 121722050 PINNACLE SECTOR II CUP 50MM 523191 S-ROM STM STD 36NK 14X09X130 526516R S-ROM STM LG 36NK 16X11X205R 563056R S-ROMSTMXXL36+21+4L 16X11X300R 526516L S-ROM STM LG 36NK 16X11X205L 523208 S-ROM STM STD 30 NK 14X8X130 526514R S-ROM STM LG 36NK 14X09X205R 550501 S-ROM SLEEVE PRX ZTT 14B-SML 550526 S-ROM SLEEVE PRX ZTT 18F-LRG 550516 S-ROM SLEEVE PRX ZTT 16F-LRG 550544 S-ROM SLEEVE PRX ZTT 22D-LRG 523393 S-ROM STM STD 42 NK 18X13X160 550503 S-ROM SLEEVE PRX ZTT 14D-SML 550523 S-ROM SLEEVE PRX ZTT 18D-SML 523194 S-ROM STM STD 36NK 20X15X165 550570 S-ROM SLEEVE PRX ZTT 12B-SML 550506 S-ROM SLEEVE PRX ZTT 14F-LRG 550513 S-ROM SLEEVE PRX ZTT 16D-SML 526518R S-ROM STM LG 36NK 18X13X215R 121722058 PINNACLE SECTOR II CUP 58MM 550515 S-ROM SLEEVE PRX ZTT 16F-SML 563060R S-ROM STMXXL36+21+8L20X15X325R 563036R S-ROMSTMXLG36+21CR4L16X11X240R 121722064 PINNACLE SECTOR II CUP 64MM 521403 S-ROM SLEEVE PRX ZTT 20B-SML 526516N S-ROM STM LG 36NK 16X11X205N 521465 S-ROM SLEEVE PRX ZTT 16B-LRG 550540 S-ROM SLEEVE PRX ZTT 20F-XXL 550545 S-ROM SLEEVE PRX ZTT 22F-SML 523192 S-ROM STM STD 36NK 16X11X150 550535 S-ROM SLEEVE PRX ZTT 20F-SML 550534 S-ROM SLEEVE PRX ZTT 20D-LRG 521425 S-ROM SLEEVE PRX ZTT 22B-LRG 523291 S-ROM STM STD 30NK 14X09X130 523195 S-ROM STM STD 36NK 22X17X165 526518N S-ROM STM LG 36NK 18X13X215N 563040L S-ROMSTMXLG36+21CR8L20X15X270L 563040R S-ROMSTMXLG36+21CR8L20X15X270R 526520R S-ROM STM LG 36NK 20X15X225R 121722062 PINNACLE SECTOR II CUP 62MM 526678 S-ROM STM STD36+21CR 18X13X160 550546 S-ROM SLEEVE PRX ZTT 22F-LRG 523206 S-ROM STM STD 30 NK 12X06X115 121722056 PINNACLE SECTOR II CUP 56MM 563038L S-ROMSTMXLG36+21CR8L18X13X255L 521405 S-ROM SLEEVE PRX ZTT 20B-LRG 563060L S-ROM STMXXL36+21+8L20X15X325L 563038R SROMSTMXLG36+21CR8L18X13X255R 550524 S-ROM SLEEVE PRX ZTT 18D-LRG 121722048 PINNACLE SECTOR II CUP 48MM 563058R S-ROM STMXXL36+21+8L18X13X315R 523193 S-ROM STM STD 36NK 18X13X160 121722060 PINNACLE SECTOR II CUP 60MM 563056L S-ROM STMXXL36+21+4L16X11X300L 550543 S-ROM SLEEVE PRX ZTT 22D-SML 526520L S-ROM STM LG 36NK 20X15X225L 523292 S-ROM STM STD 30 NK 16X11X150 521423 S-ROM SLEEVE PRX ZTT 22B-SML 526520N S-ROM STM LG 36NK 20X15X225N 521485 S-ROM SLEEVE PRX ZTT 18B-LRG 121722052 PINNACLE SECTOR II CUP 52MM PINNACLE 100 ACET CUP TRILOCK BPS PINNACLE 300 ACET CUP SUMMIT POROUS PINNACLE MULTIHOLE II CUP PINNACLE SECTOR II CUP

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)