FDA.reportPublic FDA data

MediWorks

Primary DI
06945087539019
Brand
MediWorks
Company
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Model
S390H
Device description
Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue damage of eyes.
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152429000Slit Lamp MicroscopeShanghai Mediworks Precision Instruments Co. , Ltd.2016-05-11HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945087539019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945087539019069450875390196945087539019

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

Regulatory Flags#

DUNS number
527884077
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945087505175MediworksScansys TA5172020-03-12
06945087516225MediworksFC1622021-05-18
06945087500026MediworksSM6212022-11-02
06945087500040MediWorksS2902022-11-02
06945087500057MediWorksSL650+2022-11-02
06945087500217MediWorksSL6502022-11-02
06945087515013MediworksS1502022-11-02
06945087520000MediworksRSL 21002021-05-17
06945087525005MediworksRSL 26002021-05-17
06945087525012MediworksRSL 2600digital2021-05-17
06945087590003MediworksTSL-900Z2021-05-17
06945087590010MediworksTSL-900H2021-05-17
06945087590027MediworksTSL-900Hdigital2021-05-17
06945087530023MediworksSL300L2021-05-10
06945087535066MediworksSL350H2021-05-10
06945087535073MediworksSL350L2021-05-10
06945087540015MediworksSL400H2021-05-10
06945087540022MediworksSL400L2021-05-10
06945087545010MediworksSL450H2021-05-10
06945087545027MediworksSL450L2021-05-10

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