FDA.reportPublic FDA data

BioZorb Marker GOLD

Primary DI
00851766006122
Brand
BioZorb Marker GOLD
Company
FOCAL THERAPEUTICS, INC.
Model
G0203
Device description
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
Published
2018-06-08
Public version status
New
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
K171467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171467000BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics2017-11-09IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851766006122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851766006122008517660061228517660061220851766006122

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
Length3Centimeter
Width2Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00If temperature indicator has a black center, do not use product.
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-764-7258customerservice@focalrx.com

Regulatory Flags#

DUNS number
965352946
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
00851766006108PERL Localization Device, 16Ga x 11.5cm NeedleR202017-08-01
00851766006245PERL Localization Device, 16Ga x 11.5cm NeedleR102019-07-16
00851766006009BioZorb MarkerF02022015-10-26
00851766006016BioZorb MarkerF02032015-10-26
00851766006023BioZorb MarkerF03032015-10-26
00851766006030BioZorb MarkerF03042015-10-26
00851766006047BioZorb MarkerF04042015-10-26
00851766006054BioZorb MarkerF04052015-10-26
00851766006061BioZorb LP MarkerF02212015-10-26
00851766006078BioZorb LP MarkerF02312015-10-26
00851766006085BioZorb LP MarkerF03312015-10-26
00851766006184PERL Localization Device, 16Ga x 11.5cm NeedleR152018-06-08
00851766006092PERL Localization DeviceR20202017-04-05
10851766006242PERL Localization Device, 16Ga x 11.5cm NeedleR102019-07-16
00851766006115BioZorb LP Marker GOLDG02312018-06-08
00851766006139BioZorb Marker GOLDG03032018-06-08
00851766006146BioZorb Marker GOLDG03042018-06-08
00851766006153BioZorb Marker GOLDG0203-62018-06-08
00851766006160BioZorb Marker GOLDG0303-62018-06-08
00851766006177BioZorb Marker GOLDG0304-62018-06-08

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00841439115305MultiFix 2QfixIYE2026-06-04
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00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
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