FDA.reportPublic FDA data

TIANNUO / TNMED

Primary DI
06945033901235
Brand
TIANNUO / TNMED
Company
Lianyungang Tiannuo Optical Instrument Co., Ltd.
Model
RS-5R55W
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HMHRack, Skiascopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMHRack, SkiascopicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945033901235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945033901235069450339012356945033901235

GMDN Terms#

Term, Definition table
TermDefinition
Lens expressorA manual ophthalmic surgical instrument designed for pressing or squeezing the natural lens from the eye. It is typically a hand-held device with the working end configured as a hook, ring, or other appropriate shape. This is a reusable device.

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
B945TOM1800BernellBernellHMH2026-05-03
B945CBAR40BernellBernellHMH2026-05-02
B945DSLRS80BernellBernellHMH2026-05-02
B945HTLRPS0BernellBernellHMH2026-05-02
B945L1220840BernellBernellHMH2026-05-02
B091151600Retinoscopy Rack with CompassGulden Ophthalmics Inc.HMH2023-07-05
B091151610Retinoscopy RackGulden Ophthalmics Inc.HMH2023-07-05
03664188000220VisionixLUNEAU TECHNOLOGY OPERATIONSHMH2023-06-08
06945033901211TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HMH2018-09-24