FDA UDI
Not in Commercial Distribution
🇺🇸 United States
seedSelectron
DI: 08717213036529
·
Model: 130001-15
·
Nucletron B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- seedSelectron
- Primary DI
- 08717213036529
- Version / Model
- 130001-15
- Company Name
- Nucletron B.V.
- Labeler DUNS
- 415269930
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-23
- Public Version
- 4
- Public Version Date
- 2019-07-16
- Public Version Status
- Update
- Public Device Record Key
- 9f3a06b1-7d1c-49ab-92c7-dcb66ac7c8a0
- Distribution End Date
- 2019-07-16
Device Description
SeedSelectron
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 08717213036512 | GS1 | 1 | Not in Commercial Distribution | 2019-07-16 | |
| Primary | 08717213036529 | GS1 |
Customer Contacts
- Phone
- +1(770)300-9725
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010032 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity