BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Affinity™ Tray Adhesive

    DI: 07540172016797 · Model: 034300 · CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Affinity™ Tray Adhesive
    Primary DI
    07540172016797
    Version / Model
    034300
    Catalog Number
    034300
    Company Name
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
    Labeler DUNS
    626406016
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-12
    Public Version
    3
    Public Version Date
    2022-11-01
    Public Version Status
    Update
    Public Device Record Key
    c04ee981-866b-4ec6-a91d-dd491defaad0

    Device Description

    Adherant for impression materials and plastic trays

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KOO ADHESIVE, DENTURE, POLYVINYL METHYLETHER MALEIC ACID CALCIUM-SODIUM DOUBLE SALT

    GMDN Terms

    Code Name
    16658 Dental impression material adhesive

    Identifiers

    Type ID
    Primary 07540172016797
    Direct Marking 07540172019255

    Customer Contacts

    Phone
    +1(800)265-3444
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 2 x 30mL Bottle
    Total Volume 30 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sources of ignition. Protected from light. Store in well ventilated place.