FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Varex Imaging
DI: 08718755001815
·
Model: 19409-05
·
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
- 08718755001815
- Version / Model
- 19409-05
- Company Name
- Varex Imaging Nederland B.V.
- Labeler DUNS
- 413223942
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-24
- Public Version
- 4
- Public Version Date
- 2024-08-13
- Public Version Status
- Update
- Public Device Record Key
- 2f88f02d-687b-4592-b595-0a25cd749114
- Distribution End Date
- 2024-08-13
Device Description
The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics as an accessory of an X-ray system in a professional healthcare facility environment and is intended to be holding image receptor. The device is one out of the Harmony 3-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 |
|---|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | Radiology | 892.1880 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14473 | X-ray film cassette holder | A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08718755001815 | GS1 |