FDA UDI
In Commercial Distribution
🇺🇸 United States
DIAMENTOR
DI: EPTWT110160
·
Model: DIAMENTOR K1
·
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DIAMENTOR
- Primary DI
- EPTWT110160
- Version / Model
- DIAMENTOR K1
- Catalog Number
- T11016
- Company Name
- PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
- Labeler DUNS
- 318749751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-26
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6ed73f94-9ed8-40ea-835f-de81b89bf710
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 |
|---|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | Radiology | 892.1940 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40624 | Multi-modality therapeutic radiation phantom, anthropomorphic | A device consisting of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs. It is available in both fixed and variable designs and typically include holders for ionization chambers, dosimeters or radiation measurement instruments. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used for quantitative and subjective assessments of the performance of a radiation therapy treatment planning system (RTTPS) and therapeutic radiation delivery systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EPTWT110160 | HIBCC |