FDA.reportPublic FDA data

BIOMARC® RESTORE

Primary DI
00850002461107
Brand
BIOMARC® RESTORE
Company
Carbon Medical Technologies, Inc.
Model
040156
Catalog number
040156
Device description
LOW DENSITY FIDUCIAL MARKER
Published
2021-12-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850002461104PackageGS11In Commercial Distribution
00850002461107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000246110410850002461104
00850002461107008500024611078500024611070850002461107

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 radiological 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. It is not an electromagnetic or optical spatial marker.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Length0
Width0

Contacts#

Phone, Email table
PhoneEmail
6516538512INFO@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
true
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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