Identity
- Trade Name
- HydroMARK FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- HydroMark Breast Biopsy Site Marker- Non CE FDA UDI
- Model / Reference
- 4010-05-08-T1 FDA UDI
- Description
- HydroMark Breast Biopsy Site Marker- Non CE FDA UDI
Identifiers
- Catalog Number
- CA000515004 FDA UDI
- Primary DI / UDI-DI
- 00841911103639 FDA UDI
- 510(k) Number
- K203097 FDA UDI
- FDA Product Code
- NEU FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4300 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
MR Conditional FDA UDI
Category: Radiological image marker, implantable
HydroMARK by Devicor Medical Products, Inc. — Class II — 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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Cleared under the same submission
K203097 also covers:
- HydroMARK — Devicor Medical Products, Inc.
- Hydromark — Devicor Medical Products, Inc.
- Hydromark — Devicor Medical Products, Inc.
- Hydromark — Devicor Medical Products, Inc.
- Hydromark — Devicor Medical Products, Inc.
- Mammotome HydroMARK — Devicor Medical Products, Inc.
- Mammotome HydroMARK — Devicor Medical Products, Inc.
- Mammotome HydroMARK — Devicor Medical Products, Inc.
- Mammotome HydroMARK — Devicor Medical Products, Inc.
- Mammotome HydroMARK — Devicor Medical Products, Inc.
- Mammotome HydroMARK — Devicor Medical Products, Inc.
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
- Devicor Medical Products, Inc.
Sources (1)
- FDA UDI 7d66cd01-2721-43a4-8fcd-4db2a4007490 35 fields · synced Jun 8, 2026