DEVICE: ENDOCAVITARY TRANSDUCER (04987670001604)

Device Identifier (DI) Information

ENDOCAVITARY TRANSDUCER
PVL-715RT
In Commercial Distribution

CANON MEDICAL SYSTEMS CORPORATION
04987670001604
GS1

1
690575113 *Terms of Use
ENDOCAVITARY TRANSDUCER
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
40772 Rectal ultrasound imaging system transducer
An ultrasound imaging transducer assembly specifically designed to be positioned within the rectum either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. Also known as a rectal, transrectal, or prostate probe, it may incorporate a biopsy needle guidance channel as part of the transducer casing or housing assembly design. This is a reusable device.
Obsolete false
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FDA Product Code

[?]
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 [?]
Hydrogen Peroxide
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

81d2bdea-a33b-4d6c-9612-1c2c56e6e02b
July 06, 2018
3
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1-8004211968
xxx@xxx.xxx
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