DEVICE: ImarC™ (00858015005455)

Device Identifier (DI) Information

ImarC™
040210
Not in Commercial Distribution
040210
Carbon Medical Technologies, Inc.
00858015005455
GS1
December 07, 2017
1
883094039 *Terms of Use
Tissue Marker System - Stereotactic 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.
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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
Device Size Text, specify: Cannula Gauge; 9 Gauge
CLOSE

Device Record Status

bf4424ac-64a7-44df-9988-eaf2f0f78214
March 29, 2018
2
September 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
10858015005452 10 00858015005455 2017-12-07 Not 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