DEVICE: N/A (04961333242030)

Device Identifier (DI) Information

N/A
7193-0400
In Commercial Distribution

PENTAX OF AMERICA, INC.
04961333242030
GS1

1
083211284 *Terms of Use
MICROPHONE, LARYNGEAL 9400
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
41241 Throat microphone
A battery-powered, speech-assistive device worn on the throat and designed to magnify vibrations which emanate from the throat region when the wearer is speaking to increase the volume of speech. It is an electroacoustic transducer by which electrical signals are obtained from acoustic oscillations.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EQL Laryngostroboscope
CLOSE

FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

e6cb4b9f-9800-4084-8a2f-6ea6cfb53031
April 09, 2018
1
March 08, 2018
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE