FDA UDI
Not in Commercial Distribution
🇺🇸 United States
3D Offset Imaging Set SPX1
DI: 03701311500391
·
Model: A00038
·
ECENTIAL ROBOTICS
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3D Offset Imaging Set SPX1
- Primary DI
- 03701311500391
- Version / Model
- A00038
- Company Name
- ECENTIAL ROBOTICS
- Labeler DUNS
- 261610964
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-01
- Public Version
- 2
- Public Version Date
- 2023-08-31
- Public Version Status
- Update
- Public Device Record Key
- 1864f6a0-61b4-41ec-ba51-b25305d1ffae
- Distribution End Date
- 2023-08-01
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | 892.1650 | 2 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | Radiology | 892.1650 | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47020 | Imaging lesion localization marker, external, single-use | A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701311500391 | GS1 |
Customer Contacts
- Phone
- +3345800552
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220946 | 000 |