DEVICE: ENDOVAGINAL TRANSDUCER (04987670001642)

Device Identifier (DI) Information

ENDOVAGINAL TRANSDUCER
PVM-651VT
In Commercial Distribution

CANON MEDICAL SYSTEMS CORPORATION
04987670001642
GS1

1
690575113 *Terms of Use
ENDOVAGINAL TRANSDUCER
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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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
Rectal/vaginal ultrasound imaging transducer An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. 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 another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. 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 [?]
K061605 000
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Hydrogen Peroxide
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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

73194827-adb5-4779-bd69-5e52962e7742
July 06, 2018
4
September 01, 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
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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+1-8004211968
xxx@xxx.xxx
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