Identity
- Trade Name
- Breast localisation needle FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Model / Reference
- BLM-1110-20-0050 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260277172848 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological image marker, implantable
Breast localisation needle by Möller Medical GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiological image marker, implantable.
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- HydroMark — Devicor Medical Products, Inc. · Class II
- AutoMark — M.D.L. S.R.L. · Class I
- X-Mark Ultra — IZI MEDICAL PRODUCTS LLC · Class II
- RepoMark — M.D.L. S.R.L. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Möller Medical GmbH
Sources (1)
- FDA UDI 265936f2-c0e5-434a-928a-883e456b2b19 32 fields · synced Jun 9, 2026