FDA.reportPublic FDA data

Endophotocoagulation delivery unit

Primary DI
04987669100301
Brand
Endophotocoagulation delivery unit
Company
NIDEK CO.,LTD.
Model
17118-0000
Device description
This Endophotocoagulation Delivery Unit is used for endophotocoagulation. The delivery unit is comprised of an endophoto probe, a relay adapter, a protective filter unit, and a carrying case. The photocoagulation laser system can be easily formed by connecting the endophoto probe to theGREEN LASER PHOTOCOAGULATOR Model GYC-1000 main body and connecting the protective filter to the GYC-1000 main body and the surgical microscope. This photocoagulation laser system enables endophotocoagulation with the green laser (wavelength: 532 nm) while observing theaffected area through the surgical microscope. This delivery unit is intended to be used with the protective filter unit attached to surgical microscopes. NIDEK provides following four types of delivery units according to the types of protective filters and the surgical microscopes*1.Before use, check the type of your surgical microscope and delivery unit.
Published
2017-02-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669100301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669100301049876691003014987669100301

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical frequency-doubled solid-state laser systemA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-223-9044info@nidek.com

Regulatory Flags#

DUNS number
690635461
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987669204924AUTO LENSMETERLM-12026-04-20
04987669204979AUTO LENSMETERLM-1P2026-04-20
04987669205020AUTO LENSMETERLM-1PD2026-04-20
04987669101568Scanning Laser OphthalmoscopeMirante2023-06-12
04987669100202GREEN LASER PHOTOCOAGULATOR SYSTEMGYC-10002016-06-24
04987669100226Attachable delivery unit (30SL) 17401-00002017-02-01
04987669100233Attachable delivery unit (SL-1800) 17402-00002017-02-01
04987669100240Attachable delivery unit (SL130) 17404-00002017-02-01
04987669100257Attachable delivery unit (900BQ) 17172-00002017-02-01
04987669100271BIO delivery unit (Keeler) 17120-00002017-02-03
04987669100288BIO delivery unit (Heine OMEGA)17112-00002017-02-03
04987669100295Dual delivery unit17174-00002017-02-03
04987669100318Combination attachable delivery unit (YC-1800) 17148-00002017-02-03
04987669100516OPTICAL COHERENCE TOMOGRAPHYRS-3000 Advance2016-06-24
04987669100998DIGITAL MEDICAL SCOPEDS-10F2016-09-13
04987669101001DIGITAL MEDICAL SCOPEDS-20F2017-01-27
04987669101018DIGITAL MEDICAL SCOPEDS-10A2017-01-27
04987669101025DIGITAL MEDICAL SCOPEDS-10D2017-01-31
04987669101032DIGITAL MEDICAL SCOPEDS-10E2017-01-31
04987669101049DIGITAL MEDICAL SCOPEDS-10G2017-01-31

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