IDx-DR
- Primary DI
- 00860005195626
- Brand
- IDx-DR
- Company
- Digital Diagnostics Inc.
- Model
- v2.3
- Published
- 2022-06-27
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
Code, Name table| Code | Name |
|---|
| PIB | Diabetic Retinopathy Detection Device |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| PIB | Diabetic Retinopathy Detection Device | Ophthalmic | 2 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860005195626 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
Source identifier, GTIN-14 normalized, UPC-A table| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00860005195626 | 00860005195626 | 860005195626 | 0860005195626 |
Regulatory Flags#
- DUNS number
- 028582271
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
Primary DI, Brand, Model table| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00860005195619 | IDx-DR | V2 | | 2021-07-09 |
Other Devices Sharing Product Codes#