DEVICE: Attachable delivery unit (SL-1800) (04987669100233)

Device Identifier (DI) Information

Attachable delivery unit (SL-1800)
17402-0000
In Commercial Distribution

NIDEK CO.,LTD.
04987669100233
GS1

1
690635461 *Terms of Use
This delivery unit is connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. The integrated delivery unit which incorporates the SL-1800 comprises the photocoagulation system in connection with the GYC-1000 main body. The attachable delivery unit is mainly the photocoagulation unit and the protective filter unit. They are attached to your slit lamp (NIDEK SL-1800) to comprise the integrated delivery unit. The comprised integrated delivery is connected to the GYC-1000 to comprise the photocoagulation system. This photocoagulation system allows the operator to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation of the affected area with the slit lamp.
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Device Characteristics

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

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
GEX Powered Laser Surgical Instrument
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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
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 Record Status

6f879421-aff0-483f-95a3-fbc4a632fbf5
March 29, 2018
2
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
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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