FDA.reportPublic FDA data

TIANNUO / TNMED

Primary DI
06945033901884
Brand
TIANNUO / TNMED
Company
Lianyungang Tiannuo Optical Instrument Co., Ltd.
Model
TN-S390
Device description
Motorized focusing system
Published
2016-09-24
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
K100439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100439000MEDIWORKS SLIT LAMPShanghai Mediworks Precision Instruments Co. , Ltd.2010-07-16HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945033901884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945033901884069450339018846945033901884

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
420658999
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945033901808TIANNUO / TNMEDTN-5J2016-09-24
06945033901815TIANNUO / TNMEDTN-5F2016-09-24
06945033901822TIANNUO / TNMEDTN-5F12016-09-24
06945033901839TIANNUO / TNMEDTN-5S2016-09-24
06945033901846TIANNUO / TNMEDTN-S2802016-09-24
06945033901853TIANNUO / TNMEDTN-S280S2016-09-24
06945033901860TIANNUO / TNMEDTN-S3502016-09-24
06945033901877TIANNUO / TNMEDTN-S350S2016-09-24
06945033902256TIANNUO / TNMEDTN-S3602018-06-12
06945033902263TIANNUO / TNMEDTN-S360C2018-06-12
06945033902270TIANNUO / TNMEDTN-S2602019-01-10
06945033902072TIANNUO / TNMEDTN-102A2018-09-24
06945033902089TIANNUO / TNMEDTN-5002018-09-24
06945033902096TIANNUO / TNMEDTN-510C2018-09-24
06945033902102TIANNUO / TNMEDTN-7002018-09-24
06945033902119TIANNUO / TNMEDTN-8202018-09-24
06945033902126TIANNUO / TNMEDTN-10102018-09-24
06945033902133TIANNUO / TNMEDTN-10202018-09-24
06945033902140TIANNUO / TNMEDTN-20002018-09-24
06945033902157TIANNUO / TNMEDTN-36002018-09-24

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