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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI c509e943-3e57-45b5-bb2f-52dc331835ed 33 fields · synced Jun 9, 2026