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510(k) Data Aggregation
K Number
K141438Device Name
WHITNEY MEDICAL SOLUTIONS ESHIELD
Manufacturer
WHITNEY MEDICAL SOLUTIONS
Date Cleared
2014-08-14
(76 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
WHITNEY MEDICAL SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Whitney Medical Solutions equipment drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. These drapes are used to protect the equipment from contamination during various procedures.
Device Description
The Whitney Medical Solutions' eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
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