FDA UDI
In Commercial Distribution
🇺🇸 United States
DTL 2
DI: 00855730007429
·
Model: D141
·
DIAGNOSYS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DTL 2
- Primary DI
- 00855730007429
- Version / Model
- D141
- Catalog Number
- D141
- Company Name
- DIAGNOSYS LLC
- Labeler DUNS
- 131488467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-11
- Public Version
- 2
- Public Version Date
- 2026-04-07
- Public Version Status
- Update
- Public Device Record Key
- 6d70a414-9c71-44f8-9622-3e9fc66cc035
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HLZ | Electrode, Corneal | Ophthalmic | 886.1220 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10855730007426 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 00855730007429 | GS1 |