FDA UDI
In Commercial Distribution
🇺🇸 United States
DMV Soft Lens Handler
DI: 00080875983011
·
Model: 301
·
DMV CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DMV Soft Lens Handler
- Primary DI
- 00080875983011
- Version / Model
- 301
- Catalog Number
- 301
- 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
- 1
- Public Version Date
- 2020-04-14
- Public Version Status
- New
- Public Device Record Key
- a008acc2-222e-452e-919b-b06a67806fc3
Device Description
Contact lens remover/inserter for soft contact lenses. No suction
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 |
|---|---|---|---|---|
| 37833 | Soft contact lens inserter/remover | A device designed to insert and remove a soft contact lens from the eye. It typically consists of a small, hand-held, double-prong plastic pincer with specially-designed tips to retract the lens from the eye; the device tip includes a mark and an indentation to hold the lens and facilitate its accurate placement on the eye. The device is used to avoid soft 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 |
|---|---|---|---|---|---|---|
| Package | 00080875983110 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00080875983011 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K830496 | 000 |