DEVICE: Rutilight power supply (08437016917015)

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Device Record History
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Device Identifier (DI) Information
Rutilight power supply
FA-RL01
In Commercial Distribution

SWAN MEDICAL SL.
08437016917015
GS1

1
467190738 *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?
36545 Basic power supply, reusable
A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FSQ Light, Surgical, Instrument
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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

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Storage and Handling
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 62 and 106 KiloPascal
Special Storage Condition, Specify: Keep Dry
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
5607d2cc-fc43-4b24-85a9-849023d5ccde
February 10, 2025
1
January 31, 2025
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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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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