← Back to catalogue
Gel Mark Ultra™ Breast Tissue Marker
FDA UDIClass II (US FDA UDI)
by Senorx, Inc.
Identity
- Trade Name
- Gel Mark Ultra™ Breast Tissue Marker FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- GEL MARK ULTRA™ Breast Tissue Marker, 11 Ga Mammotome, SS "Omega" FDA UDI
- Model / Reference
- MK2011 FDA UDI
- Description
- GEL MARK ULTRA™ Breast Tissue Marker, 11 Ga Mammotome, SS "Omega" FDA UDI
Identifiers
- Catalog Number
- MK2011 FDA UDI
- Primary DI / UDI-DI
- 00801741031885 FDA UDI
- 510(k) Number
- K011402 FDA UDI
- FDA Product Code
- FZP 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
- Not 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 11 Gauge FDA UDI
Gel Mark Ultra™ Breast Tissue Marker by Senorx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Senorx, Inc.
Sources (1)
- FDA UDI 9584c65e-3d3f-4ae3-a8dd-d195c3ee275f 38 fields · synced Jun 1, 2026