FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192
DI: 04049223114961
·
Model: 1321-0201
·
Eckert & Ziegler BEBIG GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192
- Primary DI
- 04049223114961
- Version / Model
- 1321-0201
- Catalog Number
- 1321-0201
- Company Name
- Eckert & Ziegler BEBIG GmbH
- Labeler DUNS
- 331080432
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-04
- Public Version
- 4
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- f548a226-0f60-46b3-b95e-07b1d0734e94
- Distribution End Date
- 2024-02-28
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 |
|---|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Radiology | 892.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38300 | Remote-afterloading brachytherapy system | An assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. A standard system consists of 1) a single radioactive source or source train in various forms; 2) a shielded vault to hold the sources when not used; 3) guide tubes/catheters to remotely direct the sources to the treatment site; 4) a remote-controlled mechanism to move the sources inside the guide tubes/catheters; 5) applicators; 6) computer treatment planning programs; and 7) an operator's console. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049223114961 | GS1 |
Customer Contacts
- Phone
- +4930941084130
- [email protected]