DEVICE: Array LaserLink (07290109143545)

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Device Identifier (DI) Information

Array LaserLink
Array LaserLink

LUMENIS INC.
07290109143545
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Slit lamp/laser system control interface A mains electricity (AC-powered) device assembly intended to be connected between a slit lamp and an ophthalmic laser system to facilitate adjustment of laser treatment settings (e.g., laser intensity, spot size and number, pattern parameters, laser beam positioning) during eye laser treatment. It consists of a laser delivery compartment designed to be attached to the slit lamp, a laser power control unit, a touchscreen, and a remote control (e.g., touchpad, 3-D mouse) which duplicates the functions of the laser system remote control.
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FDA Product Code

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Product Code Product Code Name
HQF Laser, Ophthalmic
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 01, 2016

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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

[?]
408-764-3000
xxx@xxx.xxx
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