DEVICE: Widex (05706069627442)

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Device Identifier (DI) Information

Widex
COMPASS GPS
7 503 0111 002
Widex A/S
05706069627442
GS1
1
COMPASS GPS V2.1 package (German)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Audiometric/hearing device software A software program intended to assist with the evaluation of a patient’s hearing capability, and/or function of a hearing aid or cochlear implant/sound processor, including programing according to patient-specific requirements. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet) with a wireless connection to the hearing device, or on a remote control.
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FDA Product Code

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Product Code Product Code Name
ESD Hearing Aid, Air Conduction
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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 Status

In Commercial Distribution
January 10, 2017

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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

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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4544355600
widex@widex.com
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