DMV Classic

Basic Information

• Brand Name: DMV Classic
• Primary DI: 00080875975955
• Version / Model: 595
• Company Name: DMV CORPORATION
• Labeler DUNS: 084436906
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-06
• Public Version: 2
• Public Version Date: 2020-05-12
• Public Version Status: Update
• Public Device Record Key: fa30758c-33c9-4f6d-be42-40c06db77945

Device Description

Contact lens remover/inserter with suction bulb for hard and gp contact lenses

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYE	Inserter/Remover Contact Lens	Ophthalmic	886.5420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42810	Rigid contact lens inserter/remover	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00080875975955	GS1
Package	00080875975962	GS1		10	In Commercial Distribution
Package	10080875975952	GS1	Pallet (Bag 500pcs)	500	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K830496	000