BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAGE Vitrification Kit

    DI: 60888937830448 · Model: ART-8026 · Origio A/S
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SAGE Vitrification Kit
    Primary DI
    60888937830448
    Version / Model
    ART-8026
    Company Name
    Origio A/S
    Labeler DUNS
    305424269
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-31
    Public Version
    4
    Public Version Date
    2023-07-31
    Public Version Status
    Update
    Public Device Record Key
    de3f0d36-00d7-4ead-b514-4f18cd5db09d

    Device Description

    SAGE Vitrification Kit. ART-8026 (in plastic cryo vials): 2x2 ml ART-8026-A, Equilibration Solution. 2x2 ml ART-8026-B, Vitrification Solution.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MQL Media, Reproductive

    GMDN Terms

    Code Name
    42850 IVF medium kit

    Identifiers

    Type ID
    Primary 60888937830448

    Premarket Submissions

    Submission Number Supplement Number
    K170560 000
    K173731 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius