BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PROKERA®

    DI: 00855928005145 · Model: PROKERA® PLUS · BioTissue Holdings Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PROKERA®
    Primary DI
    00855928005145
    Version / Model
    PROKERA® PLUS
    Catalog Number
    PKP
    Company Name
    BioTissue Holdings Inc.
    Labeler DUNS
    167232888
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-05
    Public Version
    3
    Public Version Date
    2023-02-06
    Public Version Status
    Update
    Public Device Record Key
    8028fc35-7d10-443b-9b71-27c559bd3292

    Device Description

    PROKERA® PLUS Biologic Corneal Bandage

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NQB Conformer, Ophthalmic, Biological Tissue

    GMDN Terms

    Code Name
    16065 Ophthalmic conformer

    Identifiers

    Type ID
    Primary 00855928005145