FDA UDI
In Commercial Distribution
🇺🇸 United States
EDITOR HFe
DI: ESPN0814001060
·
Model: 601
·
Spellman High Voltage Electronics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EDITOR HFe
- Primary DI
- ESPN0814001060
- Version / Model
- 601
- Catalog Number
- 081400106
- Company Name
- Spellman High Voltage Electronics GmbH
- Labeler DUNS
- 342494647
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-12
- Public Version
- 1
- Public Version Date
- 2021-02-22
- Public Version Status
- New
- Public Device Record Key
- 0b9dc218-44ac-4cdb-84d9-c25631791216
Device Description
EDITOR HFe601 65kW, 0,96m 400VAC 3Ph. incl. DAP interface & High Speed Starter
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 |
|---|---|---|---|---|
| 37604 | Diagnostic x-ray system generator, stationary | A generator which is an integral component of a stationary diagnostic x-ray system, e.g., a system intended to be operated at a fixed location within a facility or mobile imaging van. It is used to regulate incoming voltage and current to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It typically comprises a control assembly (console) and high voltage transformer assembly, or it is of a mono-tank generator design and includes transformer, constant potential, inverter and capacitor discharge generator designs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ESPN0814001060 | HIBCC |