FDA.reportPublic FDA data

Retinoscopy Rack

Primary DI
B091151610
Brand
Retinoscopy Rack
Company
Gulden Ophthalmics Inc.
Model
1
Published
2023-07-05
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
B091151610PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Trial lens setA set of ophthalmic trial lenses of various dioptric powers intended for vision testing to determine the required refraction. This device typically includes other related devices such as a trial frame into which the trial lenses can be rapidly exchanged during the examination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002373249
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B091230122Silicone Suction Cup (10pk)2230122024-09-04
B091230120Silicone Suction Cup (10pk)2230122024-09-04
B091230121Silicone Suction Cup (12 pk)12023-07-05
B09114150010mm Eye Sphere (non-sterile)14150141502023-07-19
B09114151012mm Eye Sphere (non-sterile)14151141512023-07-19
B09114152014mm Eye Sphere (non-sterile)14152141522023-07-19
B09114153016mm Eye Sphere (non-sterile)14153141532023-07-19
B09114154018mm Eye Sphere (non-sterile)14154141542023-07-19
B09114155020mm Eye Sphere (non-sterile)14155141552023-07-19
B09114156022mm Eye Sphere (non-sterile)14156141562023-07-19
B091112000Tangent Screen12023-07-05
B091121270Clip-on Multiple Pinhole Occluder12023-07-05
B091121280Clip-on Occluder12023-07-05
B091121310Clip-on Spielmann12023-07-05
B091151320Peds Pack12023-07-05
B091151330Brock String12023-07-05
B091151600Retinoscopy Rack with Compass12023-07-05
B091151760Color Fixation Sticks12023-07-05
B091152030Flashing Butterfly Fixation Stick12023-07-05
B091152150Pediatric Fixation Wand12023-07-05

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
03664188000220VisionixLUNEAU TECHNOLOGY OPERATIONSHMH2023-06-08
06945033901211TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HMH2018-09-24
06945033901235TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HMH2018-09-24