BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gator

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    125
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1058584
    FEI Number
    1000219637
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10811 Withers Cove Park Drive
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    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
    Bur, Ear, Nose And Throat EQJ

    Proprietary Names

    Gator Microcisor Cuda Vortex Oval Bur TOOL DC SP12MH30D LGD 12CM PROX 3 MH D BUR 312130115E VISAO CVD 3MM 115L CR DMD TOOL DC SP12BA40 LGD 12CM PROX 4 BALL BUR 31317045UE ULTRA 7MM STD LENGTH BUR 31312055 2MM STD LENGTH BUR 31316046U ULTRA 5PK 6MM STD LENGTH TOOL DC SP12MH25 LGD 12CM PROX 2.5 MH BUR TN30MCD TRANSNASAL 3MM MATCH CRS DMD TOOL DC SP12BA30 LGD 12CM PROX 3 BALL BUR 31314068U ULTRA 5PK 4MM LONG LENGTH BUR 31315059U ULTRA 5PK 5MM MED LENGTH CURVEDBUR CB11BA20 11CMX2MM BALL BUR 31311575 1.5MM STEEL X-LONG TOOL DC SP14MH25 LGD 14CM PROX 2.5 MH BUR 31314068UE ULTRA 4MM LONG LENGTH BUR 31180598E VISAO .5MM 98 L 20DG DIAMD CURVEDBUR CB11BA10D 11CMX1MM BALL DIAMND TOOL DC SD12MH30D LGD 12CM DIST 3 MH D BUR 31317057U ULTRA 5PK 7MM MED LENGTH BUR 31312075 2MM STEEL X-LONG BUR 31313565UE ULTRA 3.5MM STEEL MED L TOOL DC SP14BA40 LGD 14CM PROX 4 BALL BUR 31311570 1.5MM LONG LENGTH BUR 31312065 2MM STEEL MED LENGTH CURVEDBUR CB11BA30D 11CMX3MM BALL DIAMND TOOL DC SP12MH30 LGD 12CM PROX 3 MH BUR 312140115E VISAO CVD 4MM 115L CR DMD BUR 311710115E VISAO 1MM 115MM L 20D SST BUR 31315066UE ULTRA 5MM LONG LENGTH BUR 31311565 1.5MM STEEL MED LENGTH BUR 31314053U ULTRA 5PK 4MM STD LENGTH BUR TN40RFL TRANSNASAL 4MM RND FLUTED TOOL DC SD12MH30T LGD 12CM DIST 3 MH3F BUR 31317045U ULTRA 5PK 7MM STD LENGTH BUR 31312070 2MM LONG LENGTH TOOL DC SD12MH30 LGD 12CM DIST 3 MH BUR TN30RCD TRANSNASAL 3MM RND CRS DIAMD BUR 31312575 2.5MM STEEL X-LONG BUR 31311066 1MM STEEL MED LENGTH BUR 31312565UE ULTRA 2.5MM STL MED LGTH BUR 311920115E VISAO 2MM 115 L 20D DIAMD BUR 31154090E VISAO CVD 4MM 90L 15DEG BUR 31314075UE ULTRA 4MM STEEL X-LONG TOOL DC SP14MH25T LGD 14CM PROX 2.5 MH3F BUR 31313054U ULTRA 5PK 3MM STD LENGTH TOOL DC SP14MH30T LGD 14CM PROX 3 MH3F BUR 31204090E VISAO CVD 4MM 90L CRS DMD CURVEDBUR CB09BA10D 09CMX1MM BALL DIAMND CURVEDBUR CB09BA30D 09CMX3MM BALL DIAMND BUR 31313575UE ULTRA 3.5MM STEEL X-LONG BUR 31182090E VISAO 2MM 90 L 20DG DIAMD BUR 31184090E VISAO CVD 4MM 90L FINE DMD BUR 31313065UE ULTRA 3MM STEEL MED LGTH CURVEDBUR CB11BA40 11CMX4MM BALL BUR 31313069UE ULTRA 3MM LONG LENGTH BUR 31316058U ULTRA 5PK 6MM MED LENGTH BUR 31183090E VISAO CVD 3MM 90L FINE DMD BUR 31151598E VISAO 1.5MM 98MM L 20D SST CURVEDBUR CB09BA40D 09CMX4MM BALL DIAMND BUR 31316063UE ULTRA 6MM LONG LENGTH BUR 312120115E VISAO 2MM 115L 20D CRS DM BUR 31314065UE ULTRA 4MM MED LENGTH TOOL DC SP14MH30D LGD 14CM PROX 3 MH D BUR 31180698E VISAO CVD DIAMD .6X98MM L TOOL DC SD12BA40 LGD 12CM DIST 4 BALL BUR 31317057UE ULTRA 7MM MED LENGTH BUR 31151098E VISAO 1MM 98MM L 20DEG SST BUR 31312569 2.5MM LONG LENGTH BUR 31152090E VISAO 2MM 90MM L 20DG SST TOOL DC SP14BA30 LGD 14CM PROX 3 BALL BUR 31315047U ULTRA 5PK 5MM STD LENGTH BUR TN30MFL TRANSNASAL 3MM MATCH FLUTED BUR TN30RFL TRANSNASAL 3MM RND FLUTED CURVEDBUR CB09BA10 09CMX1MM BALL BUR 311720115E VISAO 2MM 115 L 20DG SST BUR 31313553U ULTRA 5PK 3.5MM STD LENGTH BUR TN45RCD TRANSNASAL 4.5MM RND CRS DMD BUR 31311075 1MM STEEL X-LONG CURVEDBUR CB09BA30 09CMX3MM BALL CURVEDBUR CB11BA20D 11CMX2MM BALL DIAMND BUR 311910115E VISAO 1MM 115 L 20D DIAMD BUR 311730115E VISAO CVD 3MM 115L 18DEG BUR 31317062UE ULTRA 7MM LONG LENGTH BUR 31181598E VISAO 1.5MM 98 L 20DG DIAM BUR 311715115E VISAO 1.5MM 115 L 20D SST TOOL DC SD12MH25D LGD 12CM DIST 2.5 MH D BUR 31203090E VISAO CVD 3MM 90L CRS DMD BUR 31315059UE ULTRA 5MM MED LENGTH BUR 31313069U ULTRA 5PK 3MM LONG LENGTH CURVEDBUR CB09BA40 09CMX4MM BALL CURVEDBUR CB11BA40D 11CMX4MM BALL DIAMND TOOL DC SP14MH25D LGD 14CM PROX 2.5 MH D TOOL DC SD12BA30 LGD 12CM DIST 3 BALL CURVEDBUR CB09BA20D 09CMX2MM BALL DIAMND TOOL DC SD12MH25 LGD 12CM DIST 2.5 MH BUR 31315066U ULTRA 5PK 5MM LONG LENGTH BUR 31313568U ULTRA 5PK 3.5MM LONG LENGT BUR 31313075UE ULTRA 3MM STEEL X-LONG BUR 311740115E VISAO CVD 4MM 115L 18DEG BUR 31311071 1MM LONG LENGTH BUR 311940115E VISAO CVD 4MM 115L FN DMD BUR 31316058UE ULTRA 6MM MED LENGTH BUR 31314065U ULTRA 5PK 4MM MED LENGTH BUR 31316063U ULTRA 5PK 6MM LONG LENGTH TOOL DC SP12MH25D LGD 12CM PROX 2.5 MH D BUR 31202090E VISAO 2MM 90 L 20DG DIAMD CURVEDBUR CB11BA30 11CMX3MM BALL BUR 311930115E VISAO CVD 3MM 115L FN DMD BUR TN40RCD TRANSNASAL 4MM RND CRS DIAMD BUR 31317062U ULTRA 5PK 7MM LONG LENGTH TOOL DC SP12MH25T LGD 12CM PROX 2.5 MH3F CURVEDBUR CB11BA10 11CMX1MM BALL TOOL DC SD12MH25T LGD 12CM DIST 2.5 MH3F BUR 31311056 1MM STD LENGTH BUR 31312554 2.5MM STD LENGTH BUR 31153090E VISAO CVD 3MM 90L 15DEG CURVEDBUR CB09BA20 09CMX2MM BALL TOOL DC SP12MH30T LGD 12CM PROX 3 MH3F TOOL DC SP14MH30 LGD 14CM PROX 3 MH BUR 31181098E VISAO 1MM 98 L 20DG DIAMD

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)