FDA.reportPublic FDA data

BiomarC ®

Primary DI
10858015005087
Brand
BiomarC ®
Company
Carbon Medical Technologies, Inc.
Model
040142
Catalog number
040142
Device description
Fiducial Marker - EX
Published
2015-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10858015005087PackageGS110In Commercial Distribution
00858015005080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085801500508710858015005087
00858015005080008580150050808580150050800858015005080

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter
Outer Diameter1Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8882070262info@carbonmed.com

Regulatory Flags#

DUNS number
883094039
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002461046Carbon Bright®0401510401512020-01-08
00850002461053Carbon Bright®0401520401522020-01-08
00850002461060Carbon Bright ®0401530401532020-02-18
00850002461077Carbon Bright ®0401540401542020-02-18
00850002461305BIOMARC ® EX0401650401652022-02-07
00850002461343BiomarC®0401670401672024-07-23
00850002461350Carbon Bright ®0401660401662024-07-23
00858015005059BiomarC®0401400401402015-08-07
00858015005066BiomarC ®0401010401012015-08-18
00858015005073BiomarC ®0401330401332015-08-18
00858015005080BiomarC ®0401420401422015-08-18
00858015005097BiomarC®0404000404002015-08-24
00858015005103BiomarC®0404010404012015-08-24
00858015005110BiomarC®0404020404022015-08-24
00858015005127BiomarC®0401090401092015-09-24
00858015005134BiomarC®0401150401152015-09-24
00858015005141BiomarC®0401190401192015-09-24
00858015005158BiomarC®0401200401202015-09-24
00858015005172BiomarC®0401220401222015-09-24
00858015005189BiomarC®0401230401232015-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937304eMotusEMPNIA INC.IYE2026-09-21