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510(k) Data Aggregation

    K Number
    K052668
    Device Name
    OR SPECIFIC BIG CASE BACK TABLE COVER
    Manufacturer
    Date Cleared
    2006-07-24

    (300 days)

    Product Code
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    OR SPECIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape that is intended to provide and maintain a barrier against contamination between the OR Specific dual adjustable shelf operating room equipment tables and a variety of surgical and non surgical equipment during various procedures in the clinical and hospital operating room environment. In normal use as directed this product will not make direct contact with a patient. The drape is available 4 models to meet user requirements. | Part Number | Description | |-------------|-------------| | 420HD-S | Big Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile) | | 420-S | Big Case Back Table Cover (Standard) for 6' Long Table (Sterile) | | 419HD-S | Big Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile) | | 419-S | Big Case Back Table Cover (Standard) for 5' Long Table (Sterile) | Drapes are available in two lengths to fit 5 foot long and 6 foot long OR Specific dual adjustable shelf operating room equipment tables and each length of Drape is available in a Standard and Heavy Duty version differing in the thickness and composition of the poly film fluid barrier material used in the construction of the drape.
    Device Description
    The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape manufactured using poly film and non woven material, separately and in combination designed to protect a variety of Surgical and non Surgical equipment from Contamination during various procedures throughput the clinical and operating room setting. These equipment drapes are specifically designed to fit, attach to and cover the OR Specific Big Case Back Table and function in an identical manner to other equipment drapes currently being marketed for the same intended use. 2 sizes of these covers are available designed to function with 2 different sizes of OR Specific Big Case Back Tables. In addition, the product is offered in either a standard or heavy duty version as follows. | Part Number | Description | |-------------|-------------| | 420HD-S | Big Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile) | | 420-S | Big Case Back Table Cover (Standard) for 6' Long Table (Sterile) | | 419HD-S | Big Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile) | | 419-S | Big Case Back Table Cover (Standard) for 5' Long Table (Sterile) | The drapes are packaged in heat sealed Medical grade paper and poly film pouches and ETO sterilized for convenient use in the clinical or hospital operating room environment. The OR Specific Big Case Back Table Cover is manufactured from similar materials to the predicate devices and is packaged, sterilized and labeled in a similar manner. In addition, the indications for use are similar or identical to those of the predicate devices.
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