FDA.reportPublic FDA data

X-Seed

Primary DI
EIBA2150033
Brand
X-Seed
Company
RADIOMED CORP
Model
215003
Catalog number
215003
Device description
1.15mm x 5mm X-SEED Three Pack
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
EIBA2150033PrimaryHIBCC0
EIBA2150030Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9014327202visicoil@iba-group.com

Regulatory Flags#

DUNS number
036545713
Device count
3
DM exempt
false
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
B887MR050020PL0VISICOIL MRMR-050-020-PLMR-050-020-PL2022-12-07
B887MR05000519200VISICOIL MRMR-050-005-1920MR-050-005-19202022-11-25
B887MR05001019200VISICOIL MRMR-050-010-1920MR-050-010-19202022-09-14
B887001062X-MARK Ultra0010620010622022-07-18
B887SHZ035020220VISICOIL MRSHZ-035-020-22SHZ-035-020-222022-07-18
B887SN035005PL200VISICOILSN-035-005-PL20SN-035-005-PL202022-07-18
B887SN035010PL200VISICOILSN-035-010-PL20SN-035-010-PL202022-07-18
B887SN050005PL200VISICOILSN-050-005-PL20SN-050-005-PL202022-07-18
B887SN050010PL200VISICOILSN-050-010-PL20SN-050-010-PL202022-07-18
B887SNMR05002021150VISICOIL MRSNMR-050-020-2115SNMR-050-020-21152022-07-18
B887SNMR05002021200VISICOIL MRSNMR-050-020-2120SNMR-050-020-21202022-07-18
B887001067X-MARK Ultra0010670010672022-07-18
B887MR075020PL0VISICOIL MRMR-075-020-PLMR-075-020-PL2022-07-18
B887SNMR05001021080VISICOIL MRSNMR-050-010-2108SNMR-050-010-21082022-07-18
B887SNMR05002021080VISICOIL MRSNMR-050-020-2108SNMR-050-020-21082022-07-18
B887SNMR05000521200VISICOIL MRSNMR-050-005-2120SNMR-050-005-21202022-06-24
B8870010010X-MARK0010010010012022-06-17
B8870010020X-MARK0010020010022022-06-17
B8870010030X-MARK0010030010032022-06-17
B8870010070X-MARK0010070010072022-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120562FibreplastQfixIYE2026-05-26
00840510401108KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401115KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401122KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401139KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510400088KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-17
00840510401085KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-16
00840510401092KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-16
00817355028111KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-13
00850072631035ChartCheckRadformation, IncIYE2026-03-13
00850072631059ChartCheckRadformation, IncIYE2026-03-13
00860001672770ClearCheck V2Radformation, IncIYE2026-03-13
00860001672794EZFluenceRadformation, IncIYE2026-03-13
00840510401054KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
00840510401061KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
00840510401078KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
10840277411812Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
00840510401030KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-06
00840510401047KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-06
00817355029149KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-04
00840510401016KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-02
00817355027855KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-27
00817355028265KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-27
00817355024120KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-23
00817355028968KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-23
00817355029040KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-23
00817355024878KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18
00817355025363KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18
00817355025431KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18
00817355026971KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18