FDA UDI
In Commercial Distribution
🇺🇸 United States
RETeval™
DI: 00857901006040
·
Model: RETeval Complete
·
L K C TECHNOLOGIES, INC.
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RETeval™
- Primary DI
- 00857901006040
- Version / Model
- RETeval Complete
- Catalog Number
- RETeval Complete
- Company Name
- L K C TECHNOLOGIES, INC.
- Labeler DUNS
- 606234730
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-11
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9ff78c97-ffc5-4357-b086-af709cde1d41
Device Description
RETeval visual electrophysiology system - Complete model
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HLG | Pupillometer, Ac-Powered | Ophthalmic | 886.1700 | 1 |
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
| GWE | Stimulator, Photic, Evoked Response | Neurology | 882.1890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11460 | Electroretinograph electrode | A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device. | No | Active |
| 11482 | Electroretinograph | An ophthalmic device used to record the changes in electric potential on or near the surface of the cornea to a reference distal point on the body, following stimulation of the retina by light, i.e., flashes of white light. The electroretinograph (ERG) recorder is used with a primary electrode [typically gold (Au), platinum (Pt) or silver (Ag)] and a reference electrode located almost anywhere on the body, e.g., cheek or ear lobe, and an amplifier that boosts the bioelectrical potential. Some are compatible with a personal computer (PC) for waveform storage and analysis. It is used in the diagnosis of retinal degeneration, night blindness, and circulatory disturbances of the retina. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857901006040 | GS1 |
Customer Contacts
- Phone
- 310-840-1992
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142567 | 000 |