Identity
- Trade Name
- ATEC TriMark Titanium Biopsy Site Marker EUDAMEDTriMark FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- TriMark Biopsy Site Markers EUDAMEDTriMark TrapDoor (TD) FDA UDI
- Model / Reference
- TRIMARK TD 1312 EUDAMEDFDA UDI
- Description
- TriMark TrapDoor (TD) FDA UDI
Identifiers
- Catalog Number
- TRIMARK TD 1312 FDA UDI
- Primary DI / UDI-DI
- 05420045503284 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455TRIMARKBSH5X EUDAMED
- Direct Marketing DI
- 05420045503284 EUDAMED
- 510(k) Number
- K023450 FDA UDI
- FDA Product Code
- NEU FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4300 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Radiological image marker, implantable
TriMark by Hologic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radiological image marker, implantable.
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Cleared under the same submission
K023450 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Hologic, Inc.
Sources (2)
- FDA UDI c7c8531e-1254-4c95-a2bd-ac212dc94f46 36 fields · synced Jul 25, 2026
- EUDAMED 6746b514-2b9f-4f88-8b03-78ede942b769 61 fields · synced Jul 25, 2026