Specular Microscope

Primary DI
04582273612822
Brand
Specular Microscope
Company
TOMEY CORPORATION.
Model
EM-4000
Published
2018-03-06
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

Product Codes#

Code, Name table
CodeName
NQEMicroscope, Specular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQEMicroscope, SpecularOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582273612822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582273612822045822736128224582273612822

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic examination slit lampAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
696280002
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
true
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
04582273600263NON-CONTACT TONOMETERFT-10002022-04-01
04582273603691SPECULAR MICROSCOPEEM-40002022-04-01
04582273611740NON-CONTACT TONOMETERFT-10002016-10-18
04582273612150NON-CONTACT TONOMETERFT-10002016-09-21
04582273612167NON-CONTACT TONOMETERFT-10002016-10-18
04582273604704Cornea/Anterior Segment OCTCASIA22023-06-07
04582273600218AUTO REFKERATOMETERRC-50002022-04-01
04582273600256AUTO REF-TOPOGRAPHERRT-70002022-04-01
04582273603714Topographic Modeling SystemTMS-4N2022-04-01
04582273604162Auto LensmeterTL-70002022-04-01
04582273611788AUTO REFKERATOMETERRC-8002022-04-01
04582273612679Auto LensmeterTL-60002022-04-01
04582273612242AUTO REFKERATOMETERRC-50002020-10-30
04582273612273AUTO REFKERATOMETERRC-8002020-10-30
04582273612297AUTO REF-TOPOGRAPHERRT-70002020-10-30
04582273612099TOPOGRAPHIC MODELING SYSTEMTMS-4N2020-10-30
04582273612129TOPOGRAPHIC MODELING SYSTEMTMS-4N2020-10-30
04582273612402AUTO LENSMETERTL-1002020-10-30
04582273612655AUTO LENSMETERTL-70002020-10-30
04582273612686AUTO LENSMETERTL-60002020-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852194002007EB-3000xyzHightech American Industrial Labs IncNQE2025-12-25
00852194002021EB-2000xyzHightech American Industrial Labs IncNQE2025-12-25
00852194002014HAI CL-1000xyz clinical specular microscopeHightech American Industrial Labs IncNQE2025-03-21
04582275250671NAKONAN MEDICAL, INC.NQE2023-09-27
04582275250664NAKONAN MEDICAL, INC.NQE2022-04-07
04582273603691SPECULAR MICROSCOPETOMEY CORPORATION.NQE2022-04-01
04582275250626NAKONAN MEDICAL, INC.NQE2020-04-02
04582275250374NAKONAN MEDICAL, INC.NQE2016-09-23
04582275250404NAKONAN MEDICAL, INC.NQE2016-09-23
04562123288315SPECULAR MICROSCOPE SP-1PTOPCON CORPORATIONNQE2016-09-19
04987669100530SPECULAR MICROSCOPENIDEK CO.,LTD.NQE2016-08-26