DEVICE: Endophotocoagulation Delivery Unit (04987669100981)
Device Identifier (DI) Information
Endophotocoagulation Delivery Unit
11143-0000(9M5P)
In Commercial Distribution
NIDEK CO.,LTD.
11143-0000(9M5P)
In Commercial Distribution
NIDEK CO.,LTD.
The delivery unit is used for endophotocoagulation. The photocoagulation system can be easily comprised by connecting the optional sterilized endophoto
probe or optional sterilized coaxial illumination probe to the Multicolor Laser Photocoagulator System MC-500, and attaching the protective filter to the main laser device as well as the surgical microscope. This photocoagulation system enables laser endophotocoagulation while observing the affected area through the surgical microscope.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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36150 | 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
[?]Product Code | Product Code Name |
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GEX | Powered Laser Surgical Instrument |
HQF | Laser, Ophthalmic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8c882f98-b5b6-494a-96b9-cbf0566b7357
September 16, 2019
1
September 07, 2019
September 16, 2019
1
September 07, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-223-9044
info@nidek.com
info@nidek.com