FDA UDI
In Commercial Distribution
🇺🇸 United States
OCTAVIUS
DI: EPTWT430360
·
Model: lnclinometer wireless
·
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OCTAVIUS
- Primary DI
- EPTWT430360
- Version / Model
- lnclinometer wireless
- Catalog Number
- T43036
- 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
- 2017-04-27
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c509e943-3e57-45b5-bb2f-52dc331835ed
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 |
|---|---|---|---|---|
| 40626 | Bone densitometry ultrasound phantom, test object | A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials, or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of ultrasound bone density measurement systems (bone densitometers) and associated image acquisition, display, and analysis computer programs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EPTWT430360 | HIBCC |