FDA UDI
In Commercial Distribution
🇺🇸 United States
Orpheus CAST 22 inch
DI: 07290017025018
·
Model: 01
·
ORPHEUS MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orpheus CAST 22 inch
- Primary DI
- 07290017025018
- Version / Model
- 01
- Catalog Number
- MCU-EG00401
- Company Name
- ORPHEUS MEDICAL LTD
- Labeler DUNS
- 533221750
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-05
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- bb98df9b-dff2-446a-aaa4-267c6efdac78
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017025018 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 20 | Centimeter | |
| Height | 56 | Centimeter | |
| Width | 63 | Centimeter | |
| Weight | 10.6 | Kilogram |