FDA UDI
In Commercial Distribution
🇺🇸 United States
Phosphor Storage Plate IDX S0
DI: E247G38100
·
Model: G3810
·
DÜRR DENTAL SE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Phosphor Storage Plate IDX S0
- Primary DI
- E247G38100
- Version / Model
- G3810
- Company Name
- DÜRR DENTAL SE
- Labeler DUNS
- 315563684
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-19
- Public Version
- 2
- Public Version Date
- 2025-01-31
- Public Version Status
- Update
- Public Device Record Key
- 278fdbd7-eea7-402b-b310-c32d060a16f5
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IWZ | Film, Radiographic | Radiology | 892.1840 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67230 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E247G38100 | HIBCC | ||||
| Package | E247G36201 | HIBCC | 2 | In Commercial Distribution | ||
| Package | E247G36301 | HIBCC | 2 | In Commercial Distribution |