FDA UDI
In Commercial Distribution
🇺🇸 United States
Prostate Stepper Template
DI: 08717213039858
·
Model: 189161P01-01
·
Nucletron B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Prostate Stepper Template
- Primary DI
- 08717213039858
- Version / Model
- 189161P01-01
- Company Name
- Nucletron B.V.
- Labeler DUNS
- 415269930
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-11
- Public Version
- 1
- Public Version Date
- 2018-08-13
- Public Version Status
- New
- Public Device Record Key
- 74a8a6bb-3000-4a24-97e6-c17e9edf0f38
Device Description
Front Plate Stepper, 6F
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 38427 | Prostate brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the prostate. It is designed for temporary implantation within the prostate and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 08717213017498 | GS1 | ||||
| Primary | 08717213039858 | GS1 |
Customer Contacts
- Phone
- +1(770)300-9725
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003270 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 6.0 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity