DEVICE: Cefaly® (05425018850143)

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Device Identifier (DI) Information

Cefaly®
11201

Cefaly Technology SPRL
05425018850143
GS1
3
Kit 3 electrodes for Cefaly II
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Headache analgesia electrical stimulator A non-sterile, head-worn, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine); it may also be used to treat insomnia. It typically consists of one or more electrodes, which may be self-adhesive, placed on the forehead or other parts of the face, and an external pulse generator (EPG), to provide a localized, oscillating electric field in the vicinity of the nerves. The device is typically used by a patient in the home and treatment schedules may be tailored for specific symptoms. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -20 and 45 Degrees Celsius
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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
September 17, 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: 05425018850174 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(203) 309-5670
info@cefaly.us
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