DEVICE: CW 4MHz Ultrasonic Probe (07290016734058)

Device Identifier (DI) Information

CW 4MHz Ultrasonic Probe
CW 4MHz Ultrasonic Probe
In Commercial Distribution
23-636
RIMED LTD.
07290016734058
GS1

1
600054688 *Terms of Use
CW 4MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the RIMED's Transcranial Doppler System.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Extracorporeal ultrasound imaging transducer, hand-held A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
ITX Transducer, Ultrasonic, Diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062578 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6c369b77-4aeb-4611-a2f9-db64cb33b518
July 06, 2018
4
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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