FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SDX System
DI: 03615070000408
·
Model: 1.0
·
DYN'R
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SDX System
- Primary DI
- 03615070000408
- Version / Model
- 1.0
- Catalog Number
- SDX0361V1.0
- Company Name
- DYN'R
- Labeler DUNS
- 380807099
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-02
- Public Version
- 5
- Public Version Date
- 2018-12-31
- Public Version Status
- Update
- Public Device Record Key
- 5250271e-2dea-471d-807e-5b60eef4a5ea
- Distribution End Date
- 2018-12-31
Device Description
Gating Module for Siemens 4D-CT
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 |
|---|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | Radiology | 892.5050 | 2 |
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45065 | Real-time position management respiratory gating system, optical | An assembly of electronic devices designed to track the respiratory pattern of a patient by means of optical technology to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. It provides real-time position management (RPM) and involves optical-based tracking (e.g., video, infrared, laser) of the respiratory cycle to enable irradiation control during the procedure. It may include a tracking camera connected to a dedicated personal computer workstation and a reflective chest wall/abdominal marker. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615070000408 | GS1 |
Customer Contacts
- Phone
- +0133442210734
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121845 | 000 |