FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical CT X-Ray Tube Assembly
DI: 06977501300028
·
Model: CTA201
·
Wuxi Guochen Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medical CT X-Ray Tube Assembly
- Primary DI
- 06977501300028
- Version / Model
- CTA201
- Company Name
- Wuxi Guochen Medical Technology Co., Ltd.
- Labeler DUNS
- 976891566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-08
- Public Version
- 1
- Public Version Date
- 2024-11-18
- Public Version Status
- New
- Public Device Record Key
- a5ae05ca-b0e7-44c6-9f9d-4bd22ef72f37
Device Description
Medical CT X-Ray Tube Assembly
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 |
|---|---|---|---|---|
| 16604 | X-ray system tube | A replaceable component of a medical or dental diagnostic, or therapeutic x-ray system consisting of a tube (a glass envelope enclosing a filament, anode, cathode under vacuum, and an interface for an electrical connection) designed to convert an input of electrical energy into an output of x-ray energy. It is the x-ray system component that provides a supply of electrons which are free to move, a means of getting the electrons to travel at high-speed, and providing a force which will cause them to suddenly change direction which results in x-ray production. Included are designs referred to as cold-cathode gas discharge tubes, fixed anode tubes, rotating anode tubes, quick change tubes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06977501300028 | GS1 |