Fiducial Marker Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Fiducial Marker Kit FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- Sterile placement needle (17GA ETW x 20cm) with bone wax and (1.2 x 3mm) soft tissue gold marker FDA UDI
- Model / Reference
- MTNW887830 EUDAMEDFDA UDISterile Fiducial Marker Kits (Class IIb) EUDAMED
- Description
- Sterile placement needle (17GA ETW x 20cm) with bone wax and (1.2 x 3mm) soft tissue gold marker FDA UDI
Identifiers
- Catalog Number
- MTNW887830 FDA UDI
- Primary DI / UDI-DI
- 00841439109700 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0015R08BH EUDAMED
- 510(k) Number
- K071614 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Radiological image marker, implantable
Fiducial Marker Kit by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological image marker, implantable.
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- AutoMark — M.D.L. S.R.L. · Class I
- X-Mark Ultra — IZI MEDICAL PRODUCTS LLC · Class II
Cleared under the same submission
K071614 also covers:
- Align Fiducial Marker Kit — Medtec LLC
- Align Fiducial Marker Kit — Medtec LLC
- Align Fiducial Marker Kit — Medtec LLC
- Coupled™ Fiducial Marker Kit — Medtec LLC
- Coupled™ Fiducial Marker Kit — Medtec LLC
- Coupled™ Fiducial Marker Kit — Medtec LLC
- Coupled™ Fiducial Marker Kit — Medtec LLC
- Fiducial Marker Kit — Medtec LLC
- Fiducial Marker Kit — Medtec LLC
- Fiducial Marker Kit — Medtec LLC
- Fiducial Marker Kit — Medtec LLC
- Fiducial Marker Kit — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI 0c4ffef6-6905-4bc3-bee7-d0ea085f9b28 37 fields · synced Jul 23, 2026
- EUDAMED ae33958d-87d1-4158-b951-6cb23a64d943 61 fields · synced Jul 23, 2026