FDA.reportPublic FDA data

Latex-free Rubber Suction Cups (100 units)

Primary DI
20697660004611
Brand
Latex-free Rubber Suction Cups (100 units)
Company
Oculo-Plastik Inc
Model
5360LF-1
Device description
Latex-free Rubber Suction Cups (100 units)
Published
2019-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
20697660004611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2069766000461120697660004611

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
514-381-3292sales@oculoplastik.com

Regulatory Flags#

DUNS number
257382580
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10697660003617Autoclavable Plastic Sterilisation Tray with mat, large27-10061512019-11-28
10697660003631Autoclavable Plastic Sterilisation Tray with mat27-1006752019-11-28
10697660003686Autoclavable Plastic Sterilisation Tray with mat, medium27-65452019-11-11
10697660003679Autoclavable Plastic Sterilisation Tray with mat, small27-65302019-11-07
10697660002191David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare)21-3222019-11-18
10697660002207David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare), refurb.21-322R2019-11-18
10697660002221David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare)21-3232019-11-18
10697660002245David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare), refurb21-323R2019-11-18
M87221416V95Symblepharon Ring Conformer Large, In Bulk21-416V2016-10-16
10697660001903Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare), refurb .21-275R2019-11-21
10697660001927Sutcliffe SS Shield & Retractor for the Laser (bent) (non glare), refurb.21-276R2019-11-21
10697660001965Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb.21-287R2019-11-21
10697660001989Laser SWAB SS Tissue Handler And Backstop for Laser (non glare)21-2892019-11-21
10697660001996Laser SWAB SS Tissue Handler And Backstop for Laser (non glare), refurb.21-289R2019-11-21
10697660002023Khan-Jaeger SS Lid Plate for the Laser (non glare), refurb.21-292R2019-11-21
10697660002047Jaeger SS Lid Plate for the Laser (non glare), refurb.21-295R2019-11-21
10697660003297Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends23-293Y2019-11-25
10697660003310Plastic Jaeger lid plates, t-yellow flater model with medium & large ends23-295Y2019-11-25
10697660003334Desmarres, Autoclavable plastic retractor t-yellow23-311Y2019-11-25
10697660003341Desmarres, Autoclavable plastic retractor t-yellow23-315Y2019-11-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03770020907586ScleralEaseODC INDUSTRIESKYE2026-02-21
00196527447258Zenlens Patient KitBausch & Lomb IncorporatedKYE2025-06-17
B091230122Silicone Suction Cup (10pk)Gulden Ophthalmics Inc.KYE2024-09-04
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
30697660002256Laser kitOculo-Plastik IncKYE2019-11-07