FDA.reportPublic FDA data

DMV Vented Scleral Cup

Primary DI
00080875971100
Brand
DMV Vented Scleral Cup
Company
DMV CORPORATION
Model
110
Catalog number
110
Device description
Contact lens Inserter with air channel for inserting hybrid, large soft and gp contact lenses. No suction
Published
2020-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KYEInserter/Remover Contact Lens

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830496000DMV ANGLERDmv Contact Lens Co.1983-03-09KYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080875971107PackageGS1100In Commercial Distribution
00080875971100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1008087597110710080875971107
00080875971100000808759711000808759711000080875971100

GMDN Terms#

Term, Definition table
TermDefinition
Rigid contact lens inserter/removerA device designed to insert and remove hard and semi-rigid contact lenses from the eye. It typically consists of a small, hand-held device that has a handle and a concave cup-like distal end; some devices include a vented handle that provides manually-adjustable suction for lens removal. The device is used to avoid hard and semi-rigid lens contamination and to facilitate lens removal and insertion typically by users with low dexterity, long nails, or rough fingers; it is also used by contact lens wearers in dirty environments. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084436906
Device count
1
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00080875971094DMV Scleral Cup1091092020-04-06
00080875985909DMV Ultra5905902020-04-06
00080875975016DMV Traditional5015012020-04-06
00080875975955DMV Classic5952020-04-06
00080875985916DMV Ultra5905902020-04-06
00080875975153DMV Magic Touch5155152020-04-06
00080875975856DMV 455855852020-04-06
00080875983011DMV Soft Lens Handler3013012020-04-06
00080875974231DMV Luma Serter4232020-04-06
00080875974248DMV Luma Serter Plus4244242020-04-06
00080875975160DMV Magic Touch5155152020-04-06
00080875975290DMV MiniCup5295292020-04-06
00080875975863DMV 455855852020-04-06
00080875983110DMV Soft Lens Handler3013012020-04-06

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
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
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