FDA UDI
In Commercial Distribution
🇺🇸 United States
S Spellman High Voltage Electronics Corporation
DI: 06975490630386
·
Model: 409085-007
·
Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- S Spellman High Voltage Electronics Corporation
- Primary DI
- 06975490630386
- Version / Model
- 409085-007
- Company Name
- Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd
- Labeler DUNS
- 529124841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- e51ca80f-b481-4b8f-8a71-4e2a9004a739
Device Description
Tube housing assembly, 409085-007
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 35618 | X-ray tube housing assembly, diagnostic | A metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. It may be an independent unit mounted in a tube support, or under a fluoroscopic table as a component of a radiographic system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06975490630386 | GS1 |