FDA.reportPublic FDA data

BiomarC®

Primary DI
00858015005059
Brand
BiomarC®
Company
Carbon Medical Technologies, Inc.
Model
040140
Catalog number
040140
Device description
Fiducial Marker System, EX
Published
2015-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132064000BIOMARC FIDUCIAL MARKERCarbon Medical Technologies, Inc.2014-02-28IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858015005056PackageGS13In Commercial Distribution
00858015005059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085801500505610858015005056
00858015005059008580150050598580150050590858015005059

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length5Millimeter
Needle Gauge18Gauge
Outer Diameter0.9Millimeter
Outer Diameter1Millimeter

Regulatory Flags#

DUNS number
883094039
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850002461388InjecSURE ®890-313S890-313S2026-04-09
10850002461395InjecSURE ®890-313P890-313P2026-04-09
10850002461418InjecSURE ®890-310S890-310S2026-04-09
10850002461425InjecSURE ®890-310P890-310P2026-04-09
00850002461404InjecSURE ®890-305SS890-305SS2026-04-09
00850002461435InjecSURE®890-305PS890-305PS2026-04-09
00850002461343BiomarC®0401670401672024-07-23
00850002461350Carbon Bright ®0401660401662024-07-23
10850002461340BiomarC®0401670401672024-07-23
10850002461357Carbon Bright ®0401660401662024-07-23
00858015005646BiomarC ® 0401430401432016-10-12
00850002461046Carbon Bright®0401510401512020-01-08
00850002461053Carbon Bright®0401520401522020-01-08
00850002461060Carbon Bright ®0401530401532020-02-18
00850002461077Carbon Bright ®0401540401542020-02-18
00850002461305BIOMARC ® EX0401650401652022-02-07
00858015005066BiomarC ®0401010401012015-08-18
00858015005073BiomarC ®0401330401332015-08-18
00858015005080BiomarC ®0401420401422015-08-18
00858015005097BiomarC®0404000404002015-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22