FDA.reportPublic FDA data

BiomarC®

Primary DI
00858015005035
Brand
BiomarC®
Company
Carbon Medical Technologies, Inc.
Model
040138
Catalog number
040138
Device description
Marker System, PRO
Published
2015-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132708000BIOMARC FIDUCIAL MARKERCarbon Medical Technologies, Inc.2013-12-20NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858015005035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858015005035008580150050358580150050350858015005035

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
Device Size Text, specify0
Length5Millimeter
Needle Gauge18Gauge
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
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
00858015005059BiomarC®0401400401402015-08-07
00858015005066BiomarC ®0401010401012015-08-18
00858015005073BiomarC ®0401330401332015-08-18
00858015005080BiomarC ®0401420401422015-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10851674008642SmartClipElucent Medical, Inc.NEU2026-07-08
10851674008659SmartClipElucent Medical, Inc.NEU2026-07-08
10851674008666SmartClipElucent Medical, Inc.NEU2026-07-08
00841911103653HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2026-07-07
15060391210541Sentimag CartENDOMAGNETICS LTDNEU2026-07-07
00884450435748SCOUT®MERIT MEDICAL SYSTEMS, INC.NEU2026-06-09
00884450767542SCOUT MD™Merit Medical Systems, Inc.NEU2026-06-09
00884450392850SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392867SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392874SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392881SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392935SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392942SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392959SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392966SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
10851674008574SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008581SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008598SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008604SmartClip SecureElucent Medical, Inc.NEU2026-02-16
10851674008468SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008475SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008482SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008499SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008505SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008512SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008529SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008536SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008543SmartClipElucent Medical, Inc.NEU2025-10-01
04250195612168Tumark EyeSOMATEX Medical Technologies GmbHNEU2025-07-15
04250195612175Tumark EyeSOMATEX Medical Technologies GmbHNEU2025-07-15