DEVICE: Phonak (07612904307234)

Device Identifier (DI) Information

Phonak
052-3183-D02506
In Commercial Distribution
052-3183-D02506
Phonak AG
07612904307234
GS1

1
480089517 *Terms of Use
Roger 11 Tamper Proof (02) (chestnut brown)
CLOSE

Device Characteristics

MR Unsafe
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?
57961 Hearing aid enhanced audio device, teaching-environment
A collection of battery-powered devices designed to be worn by a person (typically a child) wearing a compatible hearing aid to enhance the sound quality they receive by reducing background noise and/or room reverberation potentially found in a teaching environment (e.g., a school classroom). It uses a set frequency modulation (FM) between a transmitter worn by the speaker (e.g., a microphone worn be the teacher) and the FM receiver worn by the user. It typically consists of the FM receiver, a neck induction loop that emits the sound locally to the hearing aid, a battery charger, and various cables enabling connection to digital music devices.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ESD Hearing aid, air conduction
CLOSE

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
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

3304e2b1-de3f-41fe-8905-2defb51c1958
March 29, 2018
2
September 12, 2016
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)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+41589280101
contact@phonak.com
CLOSE