FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroSelectron Digital
DI: 08717213041455
·
Model: 080287P01-00
·
Nucletron B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MicroSelectron Digital
- Primary DI
- 08717213041455
- Version / Model
- 080287P01-00
- Company Name
- Nucletron B.V.
- Labeler DUNS
- 415269930
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c1275cda-4754-48dd-a3ad-b2a2930a25dc
Device Description
Source Loading Adapter
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 40989 | Brachytherapy system remote-afterloading operator console | A mains electricity (AC-powered) component of a remote afterloading brachytherapy system that functions as the primary control panel for the remote afterloader. It may include hardware and software that allows for information display and/or transfer, data processing, analysis, and information archiving functions. It may include an interface to a picture archiving and communication system (PACS), a radiation therapy treatment planning system, or a local area network (LAN). It differs from the workstation by only containing the primary controls for the direct operation of the system and is a freestanding unit connected to the system and located in the direct proximity. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 08717213006836 | GS1 | ||||
| Primary | 08717213041455 | GS1 |
Customer Contacts
- Phone
- +1(770)300-9725
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061354 | 000 |