FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gold Anchor
DI: 07340145700148
·
Model: GA200X-10-G
·
Naslund Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Gold Anchor
- Primary DI
- 07340145700148
- Version / Model
- GA200X-10-G
- Catalog Number
- 0014
- Company Name
- Naslund Medical AB
- Labeler DUNS
- 351991547
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-08
- Public Version
- 6
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 0f1a5900-d8b1-459e-b597-97231c28a07a
- Distribution End Date
- 2023-01-23
Device Description
Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x10 mm pre-loaded in (1) Fine Needle 20G 0.9x200 mm.
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
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 07340145700155 | GS1 | Box | 10 | Not in Commercial Distribution | 2023-01-23 |
| Primary | 07340145700148 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091645 | 000 |