BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ridge Preservation Kit - Cytoplast Technique

    DI: D765KITRPCT0 · Model: KITRPCT · Osteogenics Biomedical Inc
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ridge Preservation Kit - Cytoplast Technique
    Primary DI
    D765KITRPCT0
    Version / Model
    KITRPCT
    Company Name
    Osteogenics Biomedical Inc
    Labeler DUNS
    123853058
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-20
    Public Version
    3
    Public Version Date
    2019-05-07
    Public Version Status
    Update
    Public Device Record Key
    02eb3dde-ccae-4fbd-9aa1-5df8263a596a

    Device Description

    Ridge Preservation Kit - Cytoplast Technique; Includes: 1 sterile nonresorbable PTFE monofilament suture (model CS0518K) - USP 3-0, 18" length,16 mm 3/8 reverse cutting needle, 1 sterile nonresorbable PTFE membrane, textured (model TXT1224K) - 12 mm x 24 mm, 1 sterile GBM allograft (model C73050K) - 70% mineralized cortical bone matrix & 30% demineralized bone matrix

    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

    GMDN Terms

    Code Name
    45148 Dental/maxillofacial surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary D765KITRPCT0

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius