FDA.report

DKBL-20-5.0-A

Primary DI
00815212024115
Brand
DKBL-20-5.0-A
Company
Izi Medical Products, LLC
Model
G02586
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

Related Records

Product Codes

CodeName
MIJNeedle, Tumor Localization

Product Code Classifications

CodeDeviceSpecialtyClass
MIJNeedle, Tumor LocalizationGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815212024115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212024115008152120241158152120241150815212024115

GMDN Terms

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

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

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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

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