FDA UDI
In Commercial Distribution
🇺🇸 United States
Standard Imaging HDR 1000 Plus
DI: 00866562000212
·
Model: 90008
·
STANDARD IMAGING INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Standard Imaging HDR 1000 Plus
- Primary DI
- 00866562000212
- Version / Model
- 90008
- Catalog Number
- 90008
- Company Name
- STANDARD IMAGING INC.
- Labeler DUNS
- 788084705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 3
- Public Version Date
- 2023-06-16
- Public Version Status
- Update
- Public Device Record Key
- d8c23809-6bf3-4bd0-bd40-37826870fa88
Device Description
Standard Imaging HDR 1000 Plus is a medical device intended as a transducer for brachytherapy radiation QA measurements.
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
- No
- 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 |
|---|---|---|---|---|
| KPT | Calibrator, Dose, Radionuclide | Radiology | 892.1360 | 2 |
| IWJ | System, Applicator, Radionuclide, Manual | Radiology | 892.5650 | 1 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Radiology | 892.5700 | 2 |
| KXK | Source, Brachytherapy, Radionuclide | Radiology | 892.5730 | 2 |
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 | 00866562000212 | GS1 |