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510(k) Data Aggregation
K Number
K981069Device Name
ULTRA-COVER PU-TRANSDUCER COVER
Manufacturer
Date Cleared
1998-09-23
(183 days)
Product Code
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDICAL PRODUCTS B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Protective cover placed over diagnostic ultrasound transducer/ probe/scanhead instruments.The cover allows use of the transducer in scanning procedures for body surface, endocavity, and intra-operative diagnostic ultra-sound, while helping to prevent transfer of microorganisms, body-fluids, and material to the patient and healthcare worker during reuse of the transducer.
Ultra-Cover® PU-transducer covers are furnished sterile; single use patient/procedure, disposable.
The intended use and indications for use place Ultra-Cover® PU-transducer covers in device body contact categories as follows:
- a) surface devices, intact skin/mucosal membranes/ breached surfaces, limited contact duration . (< 24 hours)
- b) external communicating devices, blood path indirect/tissue communicating, limited contact duration (<24 hours).
Device Description
Ultra-Cover® PU-transducer covers provides an efficient, conformal covering to fit various & specific ultrasound transducer geometries. The cover helps prevent the transmission of pathogens from one patient to another.
Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required transmission gel onto the transducer face or into open end of cover, inserting ultrasound transducer into closed end of cover. The removal process is a reverse method from the application.
Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries.
Covers are packaged in both sterile and non-sterile procedure kit form for single patient/procedure, disposable use.
Product categories/models include:
General Purpose Ultra-Cover® PU-transducer covers (sterile and non sterile) Intraoperative Ultra-Cover® PU-kits (sterile)
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