BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERIPACK USA (LIMITED) LLC

    Reg #: 3009656988 · FEI: 3009656988 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    77
    Establishment Types
    3
    Classifications
    29

    Registration Details

    Registration Name
    STERIPACK USA (LIMITED) LLC
    Registration Number
    3009656988
    FEI Number
    3009656988
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4255 S Pipkin Rd
    City
    Lakeland
    State
    FL
    ZIP
    33811
    Country
    US

    Owner / Operator

    Firm Name
    SteriPack USA (Limited) LLC
    Operator Number
    10044297
    Address
    4255 South Pipkin Road
    City
    Lakeland
    State
    FL
    Postal Code
    33811
    Country
    US
    Correspondent
    Marinela Cebic

    Products

    Device Name Product Code
    Container, Specimen, Non-Sterile NNI
    Applicator, Absorbent Tipped, Sterile KXG
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Marker, Skin FZZ
    Light Source, Fiberoptic, Routine FCW
    Instrument, Biopsy KNW
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Coil, Magnetic Resonance, Specialty MOS
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Strip, Test Isoniazid MIG
    Set, Administration, Intravascular FPA
    Collector, Urine, Powered, Non Indwelling Catheter NZU
    Wound Dressing With Animal-Derived Material(S) KGN
    Tissue Adhesive For The Topical Approximation Of Skin MPN
    Marker, Radiographic, Implantable NEU
    System, Image Processing, Radiological LLZ
    Electrode, Cutaneous GXY
    Transducer, Ultrasonic, Diagnostic ITX
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Lamp, Infrared, Therapeutic Heating ILY
    Shield, Nipple HFS
    Guide, Surgical, Instrument FZX
    Syringe, Piston FMF
    Guide, Needle, Surgical GDF
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    Nasal Specimen Collection Materials SteriPack Sterile Polyester Spun Swab and Swab in Tube Sterile Flocked Swab Sterile Foam Swab Invia Foam Dressing Kit ClarifEye Markers Semi Automatic Biopsy Gun For Invivo Philips Fully Automatic Biopsy Gun for Invivo Philips Needle Block for Invivo Biopsy Device Grid dS Breast CRYOVIAL; Saliva Collection Aid (SCA) Grid Immobilization Plate BBC for Invivo Breast Biopsy Coil Needle Hub Assembly for Invivo Breast Biopsy Pillar System Pillar Immobilization Plate BBC for Invivo Breast Biopsy Coil Pillar Immobilization Plate for Invivo LBS Mammotome Device Pillar Immobilization Plate BBC for Invivio Mammotome Device Grid Immobilization Plate LBS M-L for Invivo Breast Biopsy System LBS Pillar Immobilization Plate LBS C-C for Invivo Breats Biopsy System LBS Fiducial Holder for Invivo BBC Mammotome Device Needle Block Holder for Invivo Breast Biopsy Grid System Pillar Immobilization Plate LBS M-L for Invivo Biopsy System LBS Grid Immobilization Plate LBS C-C for Invivo Breast Biopsy System LBS Leloc Tumor Localizer Biopsy Grid Plate Enteral Feeding MRI Needle Block for Invivo Biopsy Device Needle Sleeve for Invivo Biopsy Device Aspiration Biopsy MRI UriCap Family; UriCap- Female M; UriCap-Female L Puracol Ultra Powder ACTABOND Topical Skin Adhesive ClipLoc Localization Needle UroNav Sensor Clips ELECTRODE, CUTANEOUS Semi Automatic Biopsy Gun UVL1500 UVLrx Console; UVL1510 Patient Cable; UVL1520 Dry Light Adapter Contact Nipple Shield Prostate Needle Guide Allograft MIS Delivery System / ViviGen MIS Delivery System Coax Needle MRI Puncture Needle MRI Pillar Immobilization Plate OBC for Invivo Breast Biopsy Device (BBD) Grid Immobilization Plate OBC for Invivo Breast Device (BBD) 989603204314 MRI Needle Sleeve 16G 989603203524 Grid Immobilization Plate 989603203454 MRI Needle Block 8G 989603203504 MRI Needle Sleeve 14G 989603203464 MRI Needle Block 12G 989603209154 Medial Grid dS Breast 16CH 1/T 989603209094 Pillar Immobilization Plate LBS M-L 459801507722 Biopsy Grid, Sterilized [Pouch] 989603203604 Needle Hub Assembly 989603203584 Mammotome Immobilization Plate 989603209144 Lateral Grid dS Breast 16CH 1/T 989603209124 Grid Plate- Enhanced Access Medial 989603203534 Pillar Immobilization Plate 989603203484 MRI Needle Block 18G 989603209084 Grid Immobilization Plate LBS M-L 989603209104 Pillar Immobilization Plate 459801508642 Breast Grid (User-sterilized) [pouch] 989603203594 OBC Grid Immobilization Plate 989603214204 Biopsy Grid, Sterilized [Box] 989603216902 Sentinelle Biopy Grid, BOX 989603203564 Fiducial Holder 989603209074 Pillar Immobilization Plate LBS C-C 989603209134 Grid Plate- Enhanced Access Lateral 989603209064 Grid Immobilization Plate LBS 989603203494MRI Needle Sleeve 12G 459801813442 Sentinelle, Biopsy Grid [Pouch] 989603210903 Lateral Grid, Lower dS Breast 16CH I/T 989603204304 MRI Needle Block 16G 989603214224 Breast Grid (User-sterilized) [Box] 989603203474 MRI Needle Block 14G 989603203514 MRI Needle Sleeve 18G 989603210893 Lateral Grid, Upper dS Breast 16CH I/T 989603203544Needle Block Holder Sentinelle Breast Grid Plate

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Manufacture Device in the United States for Export Only