Darby Dental Supply, LLC
- Primary DI
- 10889813062002
- Brand
- Darby Dental Supply, LLC
- Company
- DARBY DENTAL SUPPLY, LLC
- Model
- 5252544
- Device description
- PHOSPHR IMGE PLATE GENDEX SZ0
- Published
- 2024-08-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EAM | Screen, intensifying, radiographic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EAM | Screen, Intensifying, Radiographic | Radiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00889813062005 | Primary | GS1 | 0 | |
| 10889813062002 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00889813062005 | 00889813062005 | 889813062005 | 0889813062005 |
| 10889813062002 | 10889813062002 | | |
GMDN Terms
| Term | Definition |
|---|
| Digital imaging phosphor plate, dental, intraoral | A thin, photostimulable, dental device intended to be placed in an appropriate cover (not included), and subsequently introduced into the oral cavity and exposed to radiation by a diagnostic imaging x-ray system to record a radiation pattern of a patient’s teeth and/or jaws. Following exposure, it is transferred, typically in a light-shielding container (not included), to a computed radiography scanner (CR) to produce a digital image of the latent image formed on the plate. This is a reusable device. |
Regulatory Flags
- DUNS number
- 825137818
- Device count
- 2
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- 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
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|---|
| 00889813067970 | Darby Dental Supply, LLC | 9537746 | | 2026-03-22 |
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| 10889813067786 | Darby Dental Supply, LLC | 9553144 | | 2025-07-02 |
| 10889813067793 | Darby Dental Supply, LLC | 9553145 | | 2025-07-02 |
| 10889813067809 | Darby Dental Supply, LLC | 9553146 | | 2025-07-02 |
| 10889813067816 | Darby Dental Supply, LLC | 9553147 | | 2025-07-02 |
| 10889813067823 | Darby Dental Supply, LLC | 9553148 | | 2025-07-02 |
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