DEVICE: TUMARK Professional (04250195600813)
Device Identifier (DI) Information
TUMARK Professional
271560
In Commercial Distribution
271560
SOMATEX Medical Technologies GmbH
271560
In Commercial Distribution
271560
SOMATEX Medical Technologies GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Imaging lesion localization marker, implantable | A sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NEU | Marker, Radiographic, Implantable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 30 Degrees Celsius |
Storage Environment Humidity: between 30 and 65 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Needle Gauge: 18 Gauge, 1,20 mm |
Device Size Text, specify: Needle Length, 120 mm |
Device Record Status
ecdbd32a-ff6f-47a4-a43c-2dfb595ebede
March 29, 2018
2
October 30, 2015
March 29, 2018
2
October 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
04250195604637 | 10 | 04250195600813 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4930319822500
info@somatex.com
info@somatex.com