Identity
- Trade Name
- DTL 2 FDA UDI
- Generic Name
- Electroretinograph electrode FDA UDI
- Device Name
- 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 and connected to gold pins. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device. FDA UDI
- Model / Reference
- D141 FDA UDI
- Description
- 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 and connected to gold pins. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- D141 FDA UDI
- Primary DI / UDI-DI
- 00855730007429 FDA UDI
- FDA Product Code
- HLZ FDA UDI
- GMDN Term
- Electroretinograph electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electroretinograph electrode
Dtl 2 by Diagnosys Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagnosys Llc
Sources (1)
- FDA UDI 6d70a414-9c71-44f8-9622-3e9fc66cc035 34 fields · synced May 30, 2026