Orpheus CAST 15 inch

FDA UDI

Class II (US FDA UDI)

by Orpheus Medical Ltd

Identity

Trade Name: Orpheus CAST 15 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-EG00407 FDA UDI
Primary DI / UDI-DI: 07290017025032 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

Category: Electrosurgical system monitor/shield

Orpheus CAST 15 inch by Orpheus Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical system monitor/shield.

AEM® Monitor, Loaner — ENCISION, INC. · Class II
AEM® Monitor -ZE — ENCISION, INC. · Class II
Disposable Sheath — ENCISION, INC. · Class II
AEM EndoShield® Burn Protection System — ENCISION, INC. · Class II
Disposable Sheath — ENCISION, INC. · Class II
AEM® Monitor — ENCISION, INC. · Class II
AEM® Monitor — ENCISION, INC. · Class II
AEM EndoShield® 2 Burn Protection System — ENCISION, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Orpheus Medical Ltd

Sources (1)

FDA UDI c407a680-26b9-4a92-b7f4-844f7c627398 34 fields · synced Jun 1, 2026