FDA UDI
In Commercial Distribution
🇺🇸 United States
SDX System
DI: 03760290230132
·
Model: V1.0
·
DYN'R
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SDX System
- Primary DI
- 03760290230132
- Version / Model
- V1.0
- Catalog Number
- SDX0361V1.0
- Company Name
- DYN'R
- Labeler DUNS
- 380807099
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-30
- Public Version
- 1
- Public Version Date
- 2018-11-30
- Public Version Status
- New
- Public Device Record Key
- dbd3abd3-b851-4da5-b4ca-ef4fc2e9939d
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 |
|---|---|---|---|---|
| 62723 | Real-time position management respiratory gating system, spirometry | An assembly of electronic devices designed to track the respiratory pattern of a patient by means of spirometry to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. It tracks the patient’s respiration using a spirometer into which the patient breaths, providing real-time measurement of the respiratory cycle to enable irradiation control during the procedure, and may include visual feedback enabling the patient to manage their own voluntary breathing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 03615070000408 | GS1 | ||||
| Primary | 03760290230132 | GS1 |
Customer Contacts
- Phone
- +33442210734
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121845 | 000 |