DEVICE: Alpine Biomed (05704736002295)

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Device Identifier (DI) Information

Alpine Biomed
9031C0512

Alpine Biomed ApS
05704736002295
GS1
1
4 ch Amp- EMG/EP Amplifier with 1.7 m cable
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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
Electromyographic signal amplifier An electronic device used with an electromyograph (EMG) to increase voltage, current, or power. This GMDN code may reflect old technology.
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FDA Product Code

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Product Code Product Code Name
GWF Stimulator, Electrical, Evoked Response
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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
October 13, 2016

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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

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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