FDA UDI
In Commercial Distribution
🇺🇸 United States
Standard Imaging Exradin W1 Scintillator
DI: 00850019946482
·
Model: 92739
·
STANDARD IMAGING INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Standard Imaging Exradin W1 Scintillator
- Primary DI
- 00850019946482
- Version / Model
- 92739
- Catalog Number
- 92739
- Company Name
- STANDARD IMAGING INC.
- Labeler DUNS
- 788084705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-22
- Public Version
- 1
- Public Version Date
- 2023-06-30
- Public Version Status
- New
- Public Device Record Key
- 2b434ffd-a780-47eb-84db-62706ca85c28
Device Description
Standard Imaging Exradin W1 Scintillator is a plastic scintillating fiber-based detector designed for highly accurate measurement of small radiotherapy fields used in patient plan verification and machine commissioning and QA procedures.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | Radiology | 892.1940 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38323 | Radiation condenser R-meter | A precise radiation counting instrument that uses a number of interchangeable radiation detection ionization probes and charger-reader mechanism. The charger is used to apply an electrostatic charge to the chamber. The drop in chamber voltage caused by a radiation field is measured in the reader. This drop in voltage is a measure of the total integrated ionization caused by the radiation. The different size and wall thickness ion chambers cover the possible range of photon energy and doses. This device is very stable over time and may be used for accurate source calibration and inter-comparison dosimetry measurements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850019946482 | GS1 |