FDA.reportPublic FDA data

Slit Lamp

Primary DI
04987669101377
Brand
Slit Lamp
Company
NIDEK CO.,LTD.
Model
SL-2000
Device description
The NIDEK SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.
Published
2017-07-03
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
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669101377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669101377049876691013774987669101377

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

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#

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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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