DEVICE: ClariTEE (00861589000108)

Device Identifier (DI) Information

ClariTEE
ClariTEE
In Commercial Distribution
CLT-010
IMACOR INC
00861589000108
GS1

1
604116553 *Terms of Use
TEE ultrasound probe, single use, EO Sterile
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Hand-held extracorporeal ultrasound imaging system A battery-powered, hand-held device/device assembly designed for collection, display, and analysis of ultrasound information during a variety of extracorporeal ultrasound imaging procedures (i.e., non-dedicated); it is not intended for intracorporeal ultrasound imaging. It consists of an ultrasound transducer with integrated image processing capability and may include a line-powered charging station; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed.
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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 [?]
K142054 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

6444b94a-6e60-4fcf-bcfd-36aa03451f6c
July 06, 2018
4
December 10, 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
20861589000102 3 00861589000108 In Commercial Distribution Box
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
516 393 0970
jkujawski@Imacorinc.com
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