DEVICE: BiomarC® (00858015005585)
Device Identifier (DI) Information
BiomarC®
040403
Not in Commercial Distribution
040403
Carbon Medical Technologies, Inc.
040403
Not in Commercial Distribution
040403
Carbon Medical Technologies, Inc.
Preloaded Carbon Tissue Marker, Needle Tip Delivery
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
40808 | Radiological image marker, implantable |
A 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 in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, 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.
|
Active | true |
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 5 Millimeter |
Outer Diameter: 1 Millimeter |
Needle Gauge: 14 Gauge |
Device Record Status
e1835bda-7aa0-4495-86c5-0720119b5e13
September 18, 2023
4
November 17, 2015
September 18, 2023
4
November 17, 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 |
---|---|---|---|---|---|
10858015005582 | 10 | 00858015005585 | 2017-12-07 | Not in Commercial Distribution | Carton |
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
[?]
8882070262
info@carbonmed.com
info@carbonmed.com