FDA UDI
In Commercial Distribution
🇺🇸 United States
DMV Luma Serter Plus
DI: 00080875974248
·
Model: 424
·
DMV CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DMV Luma Serter Plus
- Primary DI
- 00080875974248
- Version / Model
- 424
- Catalog Number
- 424
- 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
- abd4a30c-0347-4654-917b-d0c3377cae94
Device Description
45 degree Inserter for large contact lenses to be used with a pen light. 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 |
|---|---|---|---|---|
| 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 | 00080875974248 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K830496 | 000 |