AccessGUDID - DEVICE: Orpheus System (07290017025001)

GUDID

Device Identifier (DI) Information

Brand Name: Orpheus System
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MVD-0001
Company Name: ORPHEUS MEDICAL LTD

Primary DI Number: 07290017025001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533221750 *Terms of Use

Device Description: The Orpheus System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real time with video-conferencing capability during the broadcast. The Orpheus System is not intended to be used as a primary diagnostic system for mammography and any other radiology 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?
40943	Radiology picture archiving and communication system workstation	A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.	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: 7f8b1a59-a15a-498b-86d7-73b504990eb2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 05, 2017