DEVICE: Original Hanau (14054657500188)

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Device Record History
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Device Identifier (DI) Information
Original Hanau
Strahler OH C 560 SF
In Commercial Distribution
8000 4457
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
14054657500188
GS1

1
312827900 *Terms of Use
UV - Tanning lamp, Accession # 0631196-001 <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, info@original-hanau.com, http://www.original-hanau.com <CR> Manufacturer: G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com
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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 [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
3dcddf8b-67cc-4eb0-8262-e9b24018effc
March 29, 2018
2
November 01, 2016
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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
54054657600183 100 14054657500188 In Commercial Distribution CaseTertiary 100x
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+4961814902316
info@original-hanau.com
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