FDA.reportPublic FDA data

TIANNUO / TNMED

Primary DI
06945033902010
Brand
TIANNUO / TNMED
Company
Lianyungang Tiannuo Optical Instrument Co., Ltd.
Model
TN-38
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HLQKeratoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLQKeratoscope, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945033902010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945033902010069450339020106945033902010

GMDN Terms#

Term, Definition table
TermDefinition
Keratoscope, line-poweredA line-powered diagnostic ophthalmic instrument, typically hand-held, used in ophthalmic work for examining the corneal topography. The device consists of a specially designed round plate, with a concentric bore and concentric white and black rings (Placido disk). In case of astigmatism the mirror-image of the rings gives a distorted picture of the cornea of the patient being examined.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420658999
Device count
1
Premarket exempt
true
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
06945033901884TIANNUO / TNMEDTN-S3902016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09349221000033Medmont Corneal Topographer E300 USBMEDMONT INTERNATIONAL PTY LTDHLQ2022-09-14
07630003570908Leica KeratoscopeLeica Microsystems (Schweiz) AGHLQ2020-09-25
04987669101476AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2019-02-22
06945033902027TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HLQ2018-09-24
04987669100714AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2018-04-20
04987669100721AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2018-04-20
04987669100745AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2018-04-20
04987669100769HANDHELD REF / KERATOMETERNIDEK CO.,LTD.HLQ2018-04-20
00869228000472IBEX Keratometer Trevi Technology, Inc.HLQ2018-01-01
04049584000217Park 1OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLQ2016-09-01
04987669100776REFRACTIVE POWER / CORNEAL ANALYZERNIDEK CO.,LTD.HLQ2016-08-19
04987669100738AUTO REF/KERATOMETERNIDEK CO.,LTD.HLQ2016-08-10
04987669100066AUTO REF/KERATO/TONOMETERNIDEK CO.,LTD.HLQ2016-06-24