FDA.reportPublic FDA data

MediWorks

Primary DI
06945087536025
Brand
MediWorks
Company
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Model
S360S
Device description
slit lamp microscopes
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
06945087536025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945087536025069450875360256945087536025

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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