FDA UDI
In Commercial Distribution
🇺🇸 United States
CT/MR OncoSmart Catheter System
DI: 08717213024823
·
Model: 189399-00
·
Nucletron B.V.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
6
Basic Information
- Brand Name
- CT/MR OncoSmart Catheter System
- Primary DI
- 08717213024823
- Version / Model
- 189399-00
- Company Name
- Nucletron B.V.
- Labeler DUNS
- 415269930
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2017-05-25
- Public Version
- 6
- Public Version Date
- 2020-06-25
- Public Version Status
- Update
- Public Device Record Key
- 6730b3e8-fbf4-4032-92da-cb4f7bf17c9c
Device Description
Leader Insert Needle 1.5X280mm
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 38436 | General-purpose brachytherapy system applicator, remote-afterloading | A general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08717213024816 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08717213024823 | GS1 | ||||
| Unit of Use | 08717213024830 | GS1 | ||||
| Package | 08717213054448 | GS1 | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(770)300-9725
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032372 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | |||
| Length | 280.0 | Millimeter | |
| Outer Diameter | 1.5 | Millimeter |