Orpheus CAST 22 inch

FDA UDI

Class II (US FDA UDI)

by Orpheus Medical Ltd

Identity

Trade Name: Orpheus CAST 22 inch FDA UDI
Generic Name: Electrosurgical system monitor/shield FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 01 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: MCU-EG00401 FDA UDI
Primary DI / UDI-DI: 07290017025018 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: Electrosurgical system monitor/shield FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Depth — 20 Centimeter FDA UDI
Height — 56 Centimeter FDA UDI
Width — 63 Centimeter FDA UDI
Weight — 10.6 Kilogram FDA UDI

Category: Electrosurgical system monitor/shield

Orpheus CAST 22 inch by Orpheus Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Orpheus Medical Ltd

Sources (1)

FDA UDI bb98df9b-dff2-446a-aaa4-267c6efdac78 35 fields · synced Jun 1, 2026