DEVICE: PowerLaser BasicCombo (05713592020930)

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Device Identifier (DI) Information

PowerLaser BasicCombo
2093

Powermedic ApS
05713592020930
GS1
1
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
General therapeutic low-intensity laser, battery-powered A hand-held, battery-powered diode laser intended to be used to provide low-level laser therapy (LLLT) for a variety of clinical applications (e.g., to treat pain, promote healing of wounds/injuries/disorders of the joints and soft/connective tissues, for non-needle acupuncture). It typically consists of a pen-shaped applicator designed to generate laser light of wavelength 650 – 685 nm. It is intended to be operated by a healthcare provider in a clinical setting or in the home.
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FDA Product Code

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Product Code Product Code Name
ILY Lamp, Infrared, Therapeutic Heating
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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
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
November 22, 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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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