FDA.reportPublic FDA data

DMV 45

Primary DI
00080875975863
Brand
DMV 45
Company
DMV CORPORATION
Model
585
Catalog number
585
Device description
CL remover/inserter for hard and gp CL with 45° tilted suction cup
Published
2020-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00080875975863PackageGS110In Commercial Distribution
00080875975856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00080875975863000808759758630808759758630080875975863
00080875975856000808759758560808759758560080875975856

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00080875971094DMV Scleral Cup1091092020-04-06
00080875985909DMV Ultra5905902020-04-06
00080875971100DMV Vented Scleral Cup1101102020-04-06
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
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
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
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