DEVICE: RADIANCE 9000 8.5 / 100W (04014501001073)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Device Identifier (DI) Information

RADIANCE 9000 8.5 / 100W
F71 T12 100W PH / BiPin
In Commercial Distribution
26190
NARVA Lichtquellen GmbH + Co KG.
04014501001073
GS1

1
330119702 *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 [?]
Premarket Submission Number Not Available/Not Released
No 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. Attention: Fragile.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

5b7a2414-e044-4f79-b3e0-d8a07608cd94
July 24, 2025
3
June 09, 2017
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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
84014501001079 24 54014501401076 2025-07-22 Not in Commercial Distribution Pallet
54014501401076 24 04014501001073 2025-07-22 Not in Commercial Distribution Tertiary Packaging
54014501501073 25 04014501001073 In Commercial Distribution Tertiary Packaging
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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
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1 781 331 0949
info@jwnorthamerica.com
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