DEVICE: Attachable delivery unit (SL130) (04987669100141)

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Device Identifier (DI) Information

Attachable delivery unit (SL130)
17464-0000

NIDEK CO.,LTD.
04987669100141
GS1
1
The attachable delivery unit is attached to the Carl Zeiss Meditec SL 130 (hereafter called Zeiss SL 130) to comprise a slit lamp delivery unit. The comprised slit lamp delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 to comprise a photocoagulation system. The photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp. The attachable delivery unit is mainly comprised of a photocoagulation unit, a protective filter unit, and a split mirror illumination unit.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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

GMDN Preferred Term Name GMDN Definition
General/multiple surgical frequency-doubled solid-state laser system A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.
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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
February 01, 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
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None
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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1-800-223-9044
info@nidek.com
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