FDA UDI
In Commercial Distribution
🇺🇸 United States
Flexible Implant Tubes
DI: 08717213019812
·
Model: 189400-01
·
Nucletron B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Flexible Implant Tubes
- Primary DI
- 08717213019812
- Version / Model
- 189400-01
- Company Name
- Nucletron B.V.
- Labeler DUNS
- 415269930
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-02
- Public Version
- 5
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- b5c18f62-f00c-49fa-b60e-aec921be60ad
Device Description
Flexible Implant Tube Set, 6F, 30cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 08717213019812 | GS1 |
Customer Contacts
- Phone
- +1(770)300-9725
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032372 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30.0 | Centimeter | |
| Device Size Text, specify | |||
| Catheter Gauge | 6.0 | French |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius