FDA UDI
In Commercial Distribution
🇺🇸 United States
Optima
DI: 00195278524904
·
Model: IGS Ultra
·
Hangwei GE Medical Systems Co., Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Optima
- Primary DI
- 00195278524904
- Version / Model
- IGS Ultra
- Company Name
- Hangwei GE Medical Systems Co., Ltd.
- Labeler DUNS
- 654659689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-20
- Public Version
- 2
- Public Version Date
- 2023-05-31
- Public Version Status
- Update
- Public Device Record Key
- f07cd8f7-f775-4f92-9a6b-fcb5d2d733e1
Device Description
Optima IGS Ultra UDI
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
- No
- 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 |
|---|---|---|---|---|
| IZI | System, x-ray, angiographic | Radiology | 892.1600 | 2 |
| OWB | Interventional fluoroscopic x-ray system | Radiology | 892.1650 | 2 |
| JAA | System, x-ray, fluoroscopic, image-intensified | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37623 | Stationary angiographic x-ray system, digital | A stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195278524904 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181403 | 000 |