FDA.reportPublic FDA data

DKBL-20-7.0-A

Primary DI
00815212024122
Brand
DKBL-20-7.0-A
Company
Izi Medical Products, LLC
Model
G02601
Published
2021-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00815212024122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212024122008152120241228152120241220815212024122

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
DM exempt
false
Premarket exempt
true
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
00815212026973BLAZER-C CURVED INJECTION SYSTEM-MVBZK31602025-05-21
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXG800122025-03-26
00815212026942BKP-10-12.0-15.0-BG10015B2025-01-08
00815212026959BKP-11-12.0-15.0-BG11015B2025-01-08
00815212026935Duro-Ject Bone Cement Injection TubeG135502024-10-14
00815212026911KIT:BALLOON AND BONE FILLERVBBF0012024-08-28
00815212026928KIT:BALLOON,FILLER,ACCESS,DRILLVBBF0022024-08-28
10815212026895OsteoPearl Vertebral Balloon (15mm), 10G100.4122024-08-05
00815212026904OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G100.4102024-08-05
00815212024467STRYKER NAVIGATED BIOPSY NEEDLE6000-805-8002024-07-30
00815212026874BKP-10-12.0-15.0-AG10015A2024-06-28
00815212026881BKP-11-12.0-15.0-AG11015A2024-06-28
00815212026867MDT NAVIGATED BIOPSY, COMPATIABLE 7DMB3000-7D-I2024-03-18
00815212026812ONPOINT NAVIGATION KITDK02101012024-02-27
00815212026829ONPOINT NAVIGATION TRAYDP02101012024-02-27
00815212026836ONPOINT SNAP SPHERZ 25PKDS02125012024-02-27
00815212026843ONPOINT SPHERZ PASSIVE MARKER-12 PACKDS02112012024-02-27
00815212026850ONPOINT PEDICLE ACCESS NEEDLEDJ02101012024-02-27
10815212026819ONPOINT NAVIGATION 10 BOXDK02110012024-02-27
20815212026816ONPOINT NAVIGATION 25 BOXESDK02125012024-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009883703Mammo-Flex Quad-Flex Localization SystemDfc Medical LLCMIJ2023-10-17
48033003340347ALM SETH.S. HOSPITAL SERVICE SPAMIJ2023-04-19
18059174746985MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-07-15
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
04250195605825MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195605832MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604767Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604774Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604781Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604590Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604583Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604606Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
00815212024108DKBL-20-15.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024115DKBL-20-5.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024139DKBL-20-9.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024146DKBL-21-15.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024153DKBL-21-5.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024160DKBL-21-7.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024177DKBL-21-9.0-AIzi Medical Products, LLCMIJ2021-10-12
00815212024184DKBL-20-7.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024191DKBL-20-5.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024207DKBL-20-9.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024214DKBL-21-5.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024221DKBL-21-7.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024238DKBL-21-9.0-A-UIzi Medical Products, LLCMIJ2021-10-12
00815212024245DXRBL-18-5.0Izi Medical Products, LLCMIJ2021-10-12