DEVICE: Exciplex® (03760313461000)

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Device Record History
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Device Identifier (DI) Information
Exciplex®
EIPL-100
In Commercial Distribution
EIPL-PRD-K01-(US)
CLARTEIS
03760313461000
GS1

1
266012441 *Terms of Use
Exciplex® set - USA This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. Excimer light source, wavelength 308nm, optical power 2500 mW.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
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Yes
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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?
35149 Ultraviolet phototherapy unit, professional
A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is typically designed as a flat surface for lying with an overhead lamp(s), or as a chamber/cabinet, in which the patient stands, with interior walls lined with ultraviolet (UV) light tubes to allow full-body exposure and an even distribution of UV radiation. The device intended use may include psoralen + UVA therapy (oral administration of psoralen and subsequent exposure to UVA) (PUVA).
Active false
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FDA Product Code

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Product Code Product Code Name
FTC Light, Ultraviolet, Dermatological
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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 70 Degrees Celsius
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
c671befc-b925-4c4a-952e-ad6b5620acd2
September 17, 2020
1
September 09, 2020
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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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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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