FDA.reportPublic FDA data

VISICOIL MR

Primary DI
B887MR075020PL0
Brand
VISICOIL MR
Company
Izi Medical Products, LLC
Model
MR-075-020-PL
Catalog number
MR-075-020-PL
Device description
0.75mm x 2cm Platinum Fiducial MarkerPre-Loaded Needle 19g x 20cm
Published
2022-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K161724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161724000Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)Radiomed Corporation2017-04-28IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B887MR075020PL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA 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, clip, 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
19014327202VISICOIL@izimed.com

Regulatory Flags#

DUNS number
933506164
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8870010690X-MARK Ultra0010690010692022-06-17
EIBA10010X-Mark100110012016-09-23
EIBA10020X-Mark100210022016-09-23
EIBA10070X-MArk100710072016-09-23
EIBA10080X-Mark100810082016-09-23
EIBA10090X-Mark100910092016-09-23
EIBA10210X-Mark102110212016-09-23
EIBA10220X-Mark102210222016-09-23
EIBA10230X-Mark102310232016-09-23
EIBA10270X-Mark102710272016-09-23
EIBA10280X-Mark102810282016-09-23
EIBA10290X-Mark102910292016-09-23
EIBA10400X-Mark104010402017-03-16
EIBA10410X-Mark104110412016-09-23
EIBA10420X-Mark104210422016-09-23
EIBA10470X-Mark104710472016-09-23
EIBA10600X-Mark Ultra106010602016-09-23
EIBA10610X-Mark Ultra106110612016-09-23
EIBA10620X-Mark Ultra106210622016-09-23
EIBA10670X-Mark Ultra106710672016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22