ShadowForm Marker

Primary DI
00815212021695
Brand
ShadowForm Marker
Company
Izi Medical Products, LLC
Model
VIP1710
Published
2016-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KPQSystem, Simulation, Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPQSystem, Simulation, Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964972000SHADOWFORMI.Z.I. Medical Products Corp.1997-05-05KPQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212021695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212021695008152120216958152120216950815212021695

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic image marker, manualAn object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933506164
Device count
1
Lot or batch
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
00856545006003Acuity iX Radiation Therapy Simulation SystemVARIAN MEDICAL SYSTEMS, INC.KPQ2020-09-20
07540180000238Clarity®Elekta Solutions ABKPQ2020-06-19
00856545006010Varian Acuity with Conebeam Computed TomographyVARIAN MEDICAL SYSTEMS, INC.KPQ2020-06-04
07540180000221Clarity®Elekta Solutions ABKPQ2020-05-22
07540180000214Clarity®Elekta Solutions ABKPQ2019-03-27
07540180000207Clarity®Elekta LtdKPQ2018-11-19
00815212022012IZ PortsIzi Medical Products, LLCKPQ2017-02-08
00815212022050ShadowForm MarkerIzi Medical Products, LLCKPQ2017-02-07
00815212022067ShadowForm markerIzi Medical Products, LLCKPQ2017-02-07
00815212022074ShadowForm MarkerIzi Medical Products, LLCKPQ2017-02-07
00815212022111IZ PortsIzi Medical Products, LLCKPQ2017-02-02
00815212022128IZ PortsIzi Medical Products, LLCKPQ2017-02-02
00815212022135IZ PortsIzi Medical Products, LLCKPQ2017-02-02
00815212022142IZ PortsIzi Medical Products, LLCKPQ2017-02-02
07540180000184Clarity®Elekta LtdKPQ2017-01-10
00815212021701ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
00815212021718ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
00815212021725ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
00815212021732ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
00815212021749ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
07540180000016Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000023Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000030Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000047Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000054Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000061Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000078Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000085Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000092Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000108Clarity®Elekta Solutions ABKPQ2016-09-23