BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SURGICAL PROCEDURE PACK

    DI: 08056646500222 · Model: 12.XYYYY.00 · OMNIA SRL
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    60
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SURGICAL PROCEDURE PACK
    Primary DI
    08056646500222
    Version / Model
    12.XYYYY.00
    Company Name
    OMNIA SRL
    Labeler DUNS
    447696675
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-07
    Public Version
    9
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    183a0d1f-653a-41dc-ae2f-58e5d39bea87

    Device Description

    Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. Surgical Procedure Packs may be packages as a combination of any of the following components: - Surgical gowns (various models) with or without hand towels - Surgical Drapes: - Mayo drape - Absorbent/liquid proof drapes (with or without adhesive) - Adhesive side drape - Liquid repellent drape with or without adhesive - Face mask - Protective caps - Sheath/tubing sleeve - Surgical aspirator with adaptor - Surgical gauze - Disinfection sponge and/or basin - Adhesive films - Syringe - Needles - Single-use scalpel - Small dental mirror/dental explorer/tweezer - Irrigation/infusion line - Stopcock and ramp for infusion - Waste bag for contaminated material - Bone collector - Saliva ejector - Basin - Medical paper Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI" Model Number: X = alphabetic character YYYY= n° of 4 number character

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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

    Product Codes

    Code Name
    LRO General Surgery Tray (Kit)
    KKX Drape, Surgical
    FYA Gown, Surgical
    FXX Mask, Surgical

    GMDN Terms

    Code Name
    33961 General surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Package 8056646500239
    Primary 08056646500222
    Package 8056646500246
    Package 8056646500352
    Package 8056646500253
    Package 8056646500260
    Package 8056646500277
    Package 8056646500284
    Package 8056646500291
    Package 8056646500307
    Package 8056646500314
    Package 8056646500321
    Package 8056646500338
    Package 8056646500345
    Package 8056646500437
    Package 8056646500420
    Package 8056646500413
    Package 8056646500406
    Package 8056646500390
    Package 8056646500383
    Package 8056646500376
    Package 8056646500369
    Package 8056646500451
    Package 8056646500444
    Package 8056646500475
    Package 8056646500468
    Package 80566465000505
    Package 805664650505
    Package 8056646500505
    Package 8056646500512
    Package 08056646500529
    Package 08056646500536
    Package 08056646500543
    Package 08056646500550
    Package 08056646500567
    Package 08056646500581
    Package 08056646500635
    Package 08056646500628
    Package 08056646500611
    Package 08056646500574
    Package 08056646500604
    Package 08056646500598
    Package 08056646500659
    Package 08056646500666
    Package 08056646500642
    Package 08056646500673
    Package 08056646500680
    Package 08056646500697
    Package 08056646500826
    Package 08056646500819
    Package 08056646500802
    Package 08056646500796
    Package 08056646500789
    Package 08056646500772
    Package 08056646500765
    Package 08056646500758
    Package 08056646500734
    Package 08056646500727
    Package 08056646500710
    Package 08056646500703

    Customer Contacts

    Phone
    +390524527453
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K110724 000