BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SPRINT

    DI: 00854001007564 · Model: Patient Kit, Endura · SPR THERAPEUTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SPRINT
    Primary DI
    00854001007564
    Version / Model
    Patient Kit, Endura
    Catalog Number
    80035
    Company Name
    SPR THERAPEUTICS, INC.
    Labeler DUNS
    963383778
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-14
    Public Version
    3
    Public Version Date
    2021-01-08
    Public Version Status
    Update
    Public Device Record Key
    bb66e58a-5072-47b4-bbc2-f647a627635c

    Device Description

    Patient Kit, SPRINT Endura

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NIH Disinfectant, Subsystem, Water Purification

    GMDN Terms

    Code Name
    60959 Analgesic PENS system

    Identifiers

    Type ID
    Primary 00854001007564

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 55 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    -20 – 55 Degrees Celsius