FDA UDI
In Commercial Distribution
🇺🇸 United States
RTC 1000 HS
DI: 08059307491587
·
Model: 0.4/1.2
·
I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RTC 1000 HS
- Primary DI
- 08059307491587
- Version / Model
- 0.4/1.2
- Company Name
- I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA
- Labeler DUNS
- 430263475
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-23
- Public Version
- 1
- Public Version Date
- 2024-10-31
- Public Version Status
- New
- Public Device Record Key
- e0c9a870-5ed6-42cb-a8fd-57cfdaa12e19
Device Description
Rotating anode X-ray tube for radiography systems
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 |
|---|---|---|---|---|
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | Radiology | 892.1760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36593 | X-ray system tube rotating anode assembly | A component of an x-ray tube, the rotating anode subassembly provides the means to rotate a disc made of tungsten (W) or an alloy of tungsten at speeds above 3000 revolutions per minute while the x-ray tube is operational. The disc is contained within the vacuum of the glass x-ray tube. The power to effect rotation is provided by a magnetic field produced by stator coils which surround the neck of the x-ray tube outside the glass envelope. This mechanism is used in x-ray tube designs in order to dissipate the heat generated by x-ray tubes and to allow them to withstand the heat generated by large x-ray exposures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08059307491587 | GS1 |