DEVICE: BiomarC® (00858015005103)

Download: XML | JSON

Device Identifier (DI) Information

BiomarC®
040401
040401
Carbon Medical Technologies, Inc.
00858015005103
GS1
1
Preloaded Carbon Tissue Marker, Needle Tip Delivery
CLOSE

Device Characteristics

MR Safe
No
No
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. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NEU Marker, Radiographic, Implantable
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 4 Millimeter
Outer Diameter: 2 Millimeter
Needle Gauge: 13 Gauge
CLOSE

Device Status

In Commercial Distribution
August 24, 2015

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10858015005100 10 00858015005103 In Commercial Distribution Carton
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8882070262
info@carbonmed.com
CLOSE