DEVICE: MULTI-SPEECH (04961333229659)

Device Identifier (DI) Information

MULTI-SPEECH
3708
In Commercial Distribution

PENTAX OF AMERICA, INC.
04961333229659
GS1

1
083211284 *Terms of Use
Multi-Speech Microphone Preamp
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Microphone amplifier An electronic device intended to be used to increase voltage, current, or power to intensify the signal strength from a microphone.
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FDA Product Code

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Product Code Product Code Name
KLX Electroglottograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
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

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Size Type Text
No Device Sizes
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Device Record Status

69a0c22b-1940-405a-ad0a-ffe5b55502af
March 29, 2018
2
April 05, 2017
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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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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