FDA.reportPublic FDA data

DKBL-21-5.0-A-U

Primary DI
00815212024214
Brand
DKBL-21-5.0-A-U
Company
Izi Medical Products, LLC
Model
G05862
Published
2021-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MIJNeedle, Tumor Localization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIJNeedle, Tumor LocalizationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212024214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212024214008152120242148152120242140815212024214

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, external, single-useA device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933506164
Device count
1
Premarket exempt
true
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
00860009883703Mammo-Flex Quad-Flex Localization SystemDfc Medical LLCMIJ2023-10-17
08033003340349ALM SETH.S. HOSPITAL SERVICE SPAMIJ2023-04-19
48033003340347ALM SETH.S. HOSPITAL SERVICE SPAMIJ2023-04-19
08059174746964MEDWIREMEDAX SRL UNIPERSONALEMIJ2023-01-03
08059174747084MEDWIREMEDAX SRL UNIPERSONALEMIJ2023-01-03
08059174746971MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747008MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747091MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747107MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747121MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174746988MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-07-15
18059174746985MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-07-15
04250195600837TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600844TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600851TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600899Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600905Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195601605MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195601612MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195602046Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195602053Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195602060Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195603005Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195603029Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195603036Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604705TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604712TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604729TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604798Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604804Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28