FDA.reportPublic FDA data

Silicone Suction Cup (10pk)

Primary DI
B091230122
Brand
Silicone Suction Cup (10pk)
Company
Gulden Ophthalmics Inc.
Model
2
Catalog number
23012
Published
2024-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYEInserter/Remover Contact Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYEInserter/Remover Contact LensOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B091230122PrimaryHIBCC0
B091230120Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Corneal shield applicatorA hand-held manual device designed to place a shield on a patient’s cornea for protection during a medical procedure (e.g., periorbital surgery, dermatological laser treatment). It is typically in the form of a soft bulb or cup that when squeezed creates gentle suction against the shield, enabling the user to lift the shield and then gently position it on the patient’s cornea. This is a single-use device.

Regulatory Flags#

DUNS number
002373249
Device count
10
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B091152030Flashing Butterfly Fixation Stick12023-07-05
B091152150Pediatric Fixation Wand12023-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770020907593ScleralEaseODC INDUSTRIESKYE2026-03-06
03770020907586ScleralEaseODC INDUSTRIESKYE2026-02-21
00196527447258Zenlens Patient KitBausch & Lomb IncorporatedKYE2025-06-17
B091230120Silicone Suction Cup (10pk)Gulden Ophthalmics Inc.KYE2024-09-04
B091230121Silicone Suction Cup (12 pk)Gulden Ophthalmics Inc.KYE2023-07-05
00840319716632Hayden MedicalHayden Medical, Inc.KYE2022-08-03
00080875975153DMV Magic TouchDMV CORPORATIONKYE2020-04-06
00080875975856DMV 45DMV CORPORATIONKYE2020-04-06
00080875983011DMV Soft Lens HandlerDMV CORPORATIONKYE2020-04-06
00080875985909DMV UltraDMV CORPORATIONKYE2020-04-06
00080875971094DMV Scleral CupDMV CORPORATIONKYE2020-04-06
00080875971100DMV Vented Scleral CupDMV CORPORATIONKYE2020-04-06
00080875974231DMV Luma SerterDMV CORPORATIONKYE2020-04-06
00080875974248DMV Luma Serter PlusDMV CORPORATIONKYE2020-04-06
00080875975016DMV TraditionalDMV CORPORATIONKYE2020-04-06
00080875975160DMV Magic TouchDMV CORPORATIONKYE2020-04-06
00080875975290DMV MiniCupDMV CORPORATIONKYE2020-04-06
00080875975863DMV 45DMV CORPORATIONKYE2020-04-06
00080875975955DMV ClassicDMV CORPORATIONKYE2020-04-06
00080875983110DMV Soft Lens HandlerDMV CORPORATIONKYE2020-04-06
00080875985916DMV UltraDMV CORPORATIONKYE2020-04-06
20697660002617Suction Cups (12 units)Oculo-Plastik IncKYE2019-11-08
20697660004604Blue Silicone Suction Cups (100 units)Oculo-Plastik IncKYE2019-11-08
20697660004611Latex-free Rubber Suction Cups (100 units)Oculo-Plastik IncKYE2019-11-08
30697660002256Laser kitOculo-Plastik IncKYE2019-11-07