FDA UDI
In Commercial Distribution
🇺🇸 United States
GOLD MARKER NEEDLE
DI: 00812444022223
·
Model: GM1251-1720
·
RIVERPOINT MEDICAL, LLC
Product Codes
1
GMDN Terms
2
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- GOLD MARKER NEEDLE
- Primary DI
- 00812444022223
- Version / Model
- GM1251-1720
- Company Name
- RIVERPOINT MEDICAL, LLC
- Labeler DUNS
- 964053560
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-23
- Public Version
- 6
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 77bcda46-d4b7-4112-b69d-53f80816dcd6
Device Description
BRACHYTHERAPY
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33069 | Brachytherapy needle | A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device. | No | Active |
| 40808 | Radiological image marker, implantable | A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812444022223 | GS1 | ||||
| Package | 20812444022227 | GS1 | 9 | In Commercial Distribution | ||
| Package | 10812444022220 | GS1 | 5 | In Commercial Distribution | ||
| Package | 30812444022224 | GS1 | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103449 | 000 |