FDA UDI
In Commercial Distribution
🇺🇸 United States
EOS Portal
DI: 03663999000191
·
Model: 2.14
·
EOS IMAGING
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EOS Portal
- Primary DI
- 03663999000191
- Version / Model
- 2.14
- Company Name
- EOS IMAGING
- Labeler DUNS
- 762320968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-10
- Public Version
- 2
- Public Version Date
- 2024-02-15
- Public Version Status
- Update
- Public Device Record Key
- d16ca2bd-639a-4c16-9cdc-2223ff4df9dc
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60724 | Multidisciplinary medical image management software | A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03663999000191 | GS1 |