FDA.reportPublic FDA data

Tangent Screen

Primary DI
B091112000
Brand
Tangent Screen
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
HOLScreen, Tangent, Felt (Campimeter)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOLScreen, Tangent, Felt (Campimeter)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B091112000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Felt tangent screenA black tangent screen intended for assessing the extent of the patient's peripheral visual field by mapping the visual response to a test object moved from the periphery towards the centre of the screen. It typically consists of a series of concentric circles and a number of radii equally spaced around the circumference and is used in conjunction with a hand-held wand with a distal white spot or illuminated tip and black marking pins. The results are recorded manually on a corresponding chart. Also known as a Bjerrum screen.

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
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
B091151610Retinoscopy Rack12023-07-05
B091151760Color Fixation Sticks12023-07-05
B091152030Flashing Butterfly Fixation Stick12023-07-05
B091152150Pediatric Fixation Wand12023-07-05