FDA.reportPublic FDA data

Brock String

Primary DI
B091151330
Brand
Brock String
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
NXRFixation, Vision Training, Binocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXRFixation, Vision Training, BinocularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B091151330PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic binocular gaugeA noninvasive, hand-held, manual device intended to be used during an eye examination to determine objective and subjective convergence points, examine accommodation, and determine the master eye. Often called a Royal Air Force (RAF) convergence rule or RAF binocular gauge, it consists of a rule (typically 50cm long and multi-sided for taking different measurements) with a sliding test panel (typically multi-sided to allow different tests); it may have a handle at one end and a Y-shaped face rest at the other. Testing includes measuring the near distance at which, e.g., double vision is observed. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002373249
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809765430006OTUS® Fixation, Vision Training, BinocularEDENLUX Corp.NXR2025-07-07
00860010599716NeuroEyeCoachNovavision, Inc.NXR2023-07-03
00850029104650FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2023-02-05
00850029104414FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2021-03-29
08500291040492FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2021-03-29