FDA UDI
In Commercial Distribution
🇺🇸 United States
Varex Imaging
DI: 08718755000986
·
Model: 17883-10
·
Varex Imaging Nederland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Varex Imaging
- Primary DI
- 08718755000986
- Version / Model
- 17883-10
- Company Name
- Varex Imaging Nederland B.V.
- Labeler DUNS
- 413223942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-02
- Public Version
- 2
- Public Version Date
- 2021-03-18
- Public Version Status
- Update
- Public Device Record Key
- 4e99df0f-231d-4688-a6fb-53d7ff1bd8f2
Device Description
The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
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 |
|---|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | Radiology | 892.1700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38339 | Multichannel radiation survey meter | A survey meter or area monitor with a spectrometer to separate pulses received from a detector according to pulse size. Pulse size is proportional to energy of the detected radiation. It typically consists of a detector (usually a scintillation or semiconductor detector), a linear amplifier, an analogue-to-digital converter (ADC), a computer memory for storing information from the ADC, a scalar or count rate meter. The memory permits automated data processing, e.g., background subtraction and spectrum striping, which permits the analysis of complex spectra. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08718755000986 | GS1 |