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Octavius
FDA UDIClass I (US FDA UDI)
by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Identity
- Trade Name
- OCTAVIUS FDA UDI
- Generic Name
- Bone densitometry ultrasound phantom, test object FDA UDI
- Model / Reference
- lnclinometer wireless FDA UDI
Identifiers
- Catalog Number
- T43036 FDA UDI
- Primary DI / UDI-DI
- EPTWT430360 FDA UDI
- FDA Product Code
- LHO FDA UDI
- GMDN Term
- Bone densitometry ultrasound phantom, test object FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1940 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone densitometry ultrasound phantom, test object
Octavius by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone densitometry ultrasound phantom, test object.
- Phantom — medimaps group SA · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI c509e943-3e57-45b5-bb2f-52dc331835ed 33 fields · synced Jun 9, 2026