FDA.reportPublic FDA data

Flashing Butterfly Fixation Stick

Primary DI
B091152030
Brand
Flashing Butterfly Fixation Stick
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
HPLDevice, Fixation, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPLDevice, Fixation, Ac-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B091152030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic examination target holderA supportive device intended to be used during an ophthalmic examination (e.g., general eye test, dynamic retinoscopy, ophthalmoscopy) to hold a patient’s visual target in direct line of sight of the clinician, facilitating clinical observations and measurements along the visual axis. It is designed as a frame to support the visual target (e.g., mobile phone, eye test card) and has an opening through which eye observations are made; it typically includes connectors/clamps for fixation to an ophthalmic examination station and ophthalmic instruments. This device is typically used to help engage the patient when cooperation is difficult (e.g., a child or a person with a disability).

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
B091151330Brock String12023-07-05
B091151600Retinoscopy Rack with Compass12023-07-05
B091151610Retinoscopy Rack12023-07-05
B091151760Color Fixation Sticks12023-07-05
B091152150Pediatric Fixation Wand12023-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B091151320Peds PackGulden Ophthalmics Inc.HPL2023-07-05
B091151760Color Fixation SticksGulden Ophthalmics Inc.HPL2023-07-05
B091152150Pediatric Fixation WandGulden Ophthalmics Inc.HPL2023-07-05
B091153020Fixation Sticks (4pk)Gulden Ophthalmics Inc.HPL2023-07-05
B091153140Pediatric Fixation Sticks (3pk)Gulden Ophthalmics Inc.HPL2023-07-05
B091153150Face Fixation Sticks (3pk)Gulden Ophthalmics Inc.HPL2023-07-05
B091153250Flashing Fixation Sticks (2pk)Gulden Ophthalmics Inc.HPL2023-07-05