Identity
- Trade Name
- Fiducial Marker Kit FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- Sterile placement needles (17GA ETW x 30cm) with bone wax and (1.2 x 3mm) soft tissue gold marker [3] FDA UDI
- Model / Reference
- MTNW887835 FDA UDI
- Description
- Sterile placement needles (17GA ETW x 30cm) with bone wax and (1.2 x 3mm) soft tissue gold marker [3] FDA UDI
Identifiers
- Catalog Number
- MTNW887835 FDA UDI
- Primary DI / UDI-DI
- 00841439109717 FDA UDI
- 510(k) Number
- K071614 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
- 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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Radiological image marker, implantable
Fiducial Marker Kit by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — 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 (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
- Medtec LLC
Sources (1)
- FDA UDI 3ad2f095-05f0-4678-bb62-fa25121ccdd9 37 fields · synced May 30, 2026