DEVICE: MedArt Intenz (05700002070609)

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Device Record History
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Device Identifier (DI) Information
MedArt Intenz
MedArt 620
In Commercial Distribution
620.000
Medart A/S
05700002070609
GS1

1
305130079 *Terms of Use
Medical CO2 laser system for soft tissue treatments.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
61473 Dermatological carbon dioxide laser system
A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.
Active false
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FDA Product Code

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Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K120573 000
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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
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Handling Environment Humidity: less than 80 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
Weight: 20 Kilogram
Height: 20 Centimeter
Length: 60 Centimeter
Depth: 45 Centimeter
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Device Record Status
d92c61ce-70aa-47fb-9f18-31d41fa461e8
February 07, 2019
4
September 21, 2017
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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
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Customer Contact

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No Customer Contact currently defined
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