Clip-on Multiple Pinhole Occluder

Primary DI
B091121270
Brand
Clip-on Multiple Pinhole Occluder
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
HPBClip, Lens, Trial, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPBClip, Lens, Trial, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B091121270PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle lens occluderA thin, plastic, flap-like device that is clipped onto the upper frame of a pair of existing spectacles (eyeware) to block vision through the spectacle lens. It is typically made of plastic and is available in preformed, leaf-shaped, disks, usually with a pair of clip on hinges on its top edge; it is subsequently applied to the exterior of the lens. The device is often used for children and is intended to be used prophylactically (e.g., to prevent amblyopia -- impairment of vision without apparent disease) and/or therapeutically [e.g., to treat squinting, double vision (diplopia), and problems due to absence of a natural lens (aphakia)]. This is a reusable device.

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
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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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B945BC12701000BernellBernellHPB2026-05-03
B945BC1270100NI0BernellBernellHPB2026-05-03
B945BC12701250BernellBernellHPB2026-05-03
B945BC1270125NI0BernellBernellHPB2026-05-03
B945BC12701500BernellBernellHPB2026-05-03
B945BC1270150NI0BernellBernellHPB2026-05-03
B945BC12701750BernellBernellHPB2026-05-03
B945BC1270175NI0BernellBernellHPB2026-05-03
B945BC12702000BernellBernellHPB2026-05-03
B945BC1270200NI0BernellBernellHPB2026-05-03
B945BC12702250BernellBernellHPB2026-05-03
B945BC1270225NI0BernellBernellHPB2026-05-03
B945BC1270250BernellBernellHPB2026-05-03
B945BC12702500BernellBernellHPB2026-05-03
B945BC1270250NI0BernellBernellHPB2026-05-03
B945BC127025500BernellBernellHPB2026-05-03
B945BC12702550NI0BernellBernellHPB2026-05-03
B945BC127025NI0BernellBernellHPB2026-05-03
B945BC12702750BernellBernellHPB2026-05-03
B945BC1270275NI0BernellBernellHPB2026-05-03
B945BC12703000BernellBernellHPB2026-05-03
B945BC1270300NI0BernellBernellHPB2026-05-03
B945BC12703250BernellBernellHPB2026-05-03
B945BC1270325NI0BernellBernellHPB2026-05-03
B945BC12703500BernellBernellHPB2026-05-03
B945BC1270350NI0BernellBernellHPB2026-05-03
B945BC12703750BernellBernellHPB2026-05-03
B945BC1270375NI0BernellBernellHPB2026-05-03
B945BC12704000BernellBernellHPB2026-05-03
B945BC1270400NI0BernellBernellHPB2026-05-03