FDA.reportPublic FDA data

VISICOIL MR

Primary DI
B887SHZ035020220
Brand
VISICOIL MR
Company
Izi Medical Products, LLC
Model
SHZ-035-020-22
Catalog number
SHZ-035-020-22
Device description
0.35mm x 2cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Published
2022-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
JAKSystem, X-Ray, Tomography, ComputedRadiology2

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
B887SHZ035020220PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1 901-432-7202VISICOIL@izimed.com

Regulatory Flags#

DUNS number
933506164
Device count
1
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8872150044X-Seed2150042150042020-04-30
B8872850033X-Seed2850032850032020-04-30
B8872850044X-Seed2850042850042020-04-30
B887GF10033VISICOIL MRGF1003GF10032021-09-17
B887GF10044VISICOIL MRGF1004GF10042021-09-17
B887GF13233VISICOIL MRGF1323GF13232021-09-17
B887GF15033Gold FiducialGF1503GF15032021-09-17
B887MR250100VISICOIL MRMR-250102025-10-22
B887MR275100Platinum Fiducial MarkerMR-275102025-10-22
B887MR275515180Platinum Fiducial MarkerMR-275-515182025-10-22
B887MR375050Platinum Fiducial MarkerMR-375052025-10-22
B887MR475050Platinum Fiducial MarkerMR-475052025-10-22
SNMR05000521200VISICOIL MRSNMR-050-005-2120SNMR-050-005-21202022-05-13
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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