BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Knit-Pak

    DI: 00348783001884 · Model: 9007553 · PREMIER DENTAL PRODUCTS COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Knit-Pak
    Primary DI
    00348783001884
    Version / Model
    9007553
    Company Name
    PREMIER DENTAL PRODUCTS COMPANY
    Labeler DUNS
    014789663
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-29
    Public Version
    2
    Public Version Date
    2024-01-10
    Public Version Status
    Update
    Public Device Record Key
    f1b03c0c-f991-4a55-99ff-2d27fedfb289

    Device Description

    Knit-Pak™ Knitted Retraction Size 0

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NYF Gingival Retraction Kit

    GMDN Terms

    Code Name
    35861 Gingival retraction cord, non-medicated

    Identifiers

    Type ID
    Primary 00348783001884