Identity
- Trade Name
- Gold Anchor FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x10 mm pre-loaded in (1) Fine Needle 25G 0.5x150 mm. FDA UDI
- Model / Reference
- GA150-10-G FDA UDI
- Description
- Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.28x10 mm pre-loaded in (1) Fine Needle 25G 0.5x150 mm. FDA UDI
Identifiers
- Catalog Number
- 0002 FDA UDI
- Primary DI / UDI-DI
- 07340145700025 FDA UDI
- 510(k) Number
- K091645 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Gold Anchor by Naslund Medical AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Naslund Medical AB
Sources (1)
- FDA UDI 2a1a3b3e-08c4-437d-8a8f-b1ddb4664024 36 fields · synced May 30, 2026