AccessGUDID - DEVICE: Orpheus CAST 15 inch (07290017025032)

GUDID

Device Identifier (DI) Information

Brand Name: Orpheus CAST 15 inch
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCU-EG00407
Company Name: ORPHEUS MEDICAL LTD

Primary DI Number: 07290017025032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533221750 *Terms of Use

Device Description: Application for sending a live video stream from the medical operating theater to remote viewers. The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
36152	Electrosurgical system monitor/shield	A dedicated unit designed to interface with an electrosurgical system to help detect and manage high frequency leakage of current from active electrodes used in combination with endoscopes or other instruments during endoscopic procedures (especially laparoscopic).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

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: c407a680-26b9-4a92-b7f4-844f7c627398
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 05, 2017