BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    U.S. IOL, Inc.

    DI: 00814106016144 · Model: US-8002LZS · U.S. IOL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    U.S. IOL, Inc.
    Primary DI
    00814106016144
    Version / Model
    US-8002LZS
    Catalog Number
    US-8002LZS
    Company Name
    U.S. IOL, INC.
    Labeler DUNS
    604739490
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-22
    Public Version
    2
    Public Version Date
    2021-02-05
    Public Version Status
    Update
    Public Device Record Key
    c6d80e8a-a8ae-4db7-a832-dc9759072b16

    Device Description

    8/0 Micro Spatula, Double-Armed Silk Suture

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    GAP SUTURE, NONABSORBABLE, SILK

    GMDN Terms

    Code Name
    13910 Silk suture

    Identifiers

    Type ID
    Package 00814106016151
    Primary 00814106016144

    Customer Contacts

    Phone
    +1(859)259-4925
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K024091 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius