AccessGUDID - DEVICE: OCTAVIUS (EPTWT430360)

GUDID

Device Identifier (DI) Information

Brand Name: OCTAVIUS
Version or Model: lnclinometer wireless
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T43036
Company Name: PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Primary DI Number: EPTWT430360
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 318749751 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHO	Instrument, Quality-Assurance, Radiologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c509e943-3e57-45b5-bb2f-52dc331835ed
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 27, 2017