Identity
- Trade Name
- Hawkins BLN EUDAMEDBreast Localization Needles FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- Hawkins III Hardwire BLN EUDAMEDHawkins™ III Hardwire BLN 20ga x 5cm FDA UDI
- Model / Reference
- 243050 EUDAMEDFDA UDI
- Description
- Hawkins™ III Hardwire BLN 20ga x 5cm FDA UDI
Identifiers
- Catalog Number
- 243050 FDA UDI
- Primary DI / UDI-DI
- 20886333003703 EUDAMED00886333003709 FDA UDI
- Basic UDI-DI
- B-20886333003703 EUDAMED
- FDA Product Code
- GDM FDA UDI
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Category: Radiological image marker, implantable
Breast Localization Needles by Argon Medical Devices, Inc. — Class I — MDD, 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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- X-Mark Ultra — IZI MEDICAL PRODUCTS LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (2)
- FDA UDI a0d35ded-5574-46c3-a1d2-77a7c8730f75 37 fields · synced Jun 20, 2026
- EUDAMED 5c65f588-e316-4ddd-a3f6-36e634010d4d 61 fields · synced Jun 20, 2026