FDA.reportPublic FDA data

Attachable delivery unit (30SL/M)

Primary DI
04987669100875
Brand
Attachable delivery unit (30SL/M)
Company
NIDEK CO.,LTD.
Model
17431-0000
Device description
The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photocoagulation system and to treat affected areas using a
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669100875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669100875049876691008754987669100875

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987669204610Open-field Refraction SystemPHANTOM2026-01-08
04987669204917Open-field Refraction SystemPHANTOM Conrtol Box2026-01-08
04987669200018 A-scan probe14130-00012023-07-10
04987669200049 Pachymetry probe (45° fixed type)14130-00062023-07-10
04987669200070A-scan probe14610-00062023-07-10
04987669200094Pachymetry probe14610-01072023-07-10
04987669200100Pachymetry probe (45° fixed type)14610-01082023-07-10
04987669200117 A-scan probe14611-00062023-07-10
04987669200780IOL-Station1.212023-07-10
04987669100844IOL-Station1.202023-06-12
04987669101544MICROPERIMETERMP-3 type S2023-06-12
04987669101568Scanning Laser OphthalmoscopeMirante2023-06-12
04987669101711REFRACTORRT-6002023-06-12
04987669200636Image filing software NAVIS-EX1.122023-06-12
04987669200773AL-Scan Viewer for NAVIS-EX1.32023-06-12
04987669203477OPTICAL BIOMETERAL-Scan39NNNN2023-06-12
04987669203651OPTICAL BIOMETERAL-Scan32NNNN2023-06-12
04987669607350CEM Viewer for NAVIS-EX1.12023-06-12
04987669101575CHART PROJECTORCP-92021-10-01
04987669101452Ophthalmic YAG Laser SystemYC-2002021-09-24

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Primary DI, Brand, Company table
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03830074980024MR Q SLTMeridian Medical d.o.o.HQF2025-10-20
03830074980048Merilas Meridian Medical d.o.o.HQF2025-10-20
07290110123741Alma Pixel 30W 120V 50/60Hz Black (Inc)ALMA LASERS LTD.HQF2025-08-11
07290018686058Voyager DSLTBELKIN VISION LTDHQF2025-07-16
07290110123680Pixel CO2 30W 120V 50/60Hz Black (Inc)ALMA LASERS LTD.HQF2025-07-08
03700542625958CAPSULOQUANTEL MEDICALHQF2025-03-25
05700002165466Norlase LYNX photocoagulatorNorlase ApSHQF2024-10-30
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