DEVICE: Ergoline/SUNRISE 480 Turbo Power (Sound & Ambient Light), Soltron V-55 UNIVERSE (EJKP100003178A0)

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Device Record History
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Device Identifier (DI) Information
Ergoline/SUNRISE 480 Turbo Power (Sound & Ambient Light), Soltron V-55 UNIVERSE
JK 98 / 48-0
In Commercial Distribution

JK-Products GmbH
EJKP100003178A0
HIBCC

1
316232073 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46387 Ultraviolet tanning device
A mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LEJ Booth, Sun Tan
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K151400 000
No CLOSE

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

[?]
Size Type Text
No Device Sizes
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Device Record Status
060ff22a-76ed-4d9c-a6ba-b53ebc27be70
July 06, 2018
3
September 24, 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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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