FDA.reportPublic FDA data

Navigated Biopsy Needle, GPS

Primary DI
00815212024375
Brand
Navigated Biopsy Needle, GPS
Company
Izi Medical Products, LLC
Model
6143.1828S
Device description
Globus Brain Biopsy Needle
Published
2020-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143241000MDT Navigable Brain Biopsy CannulaIzi Medical Products, LLC2015-04-13HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212024375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212024375008152120243758152120243750815212024375

GMDN Terms#

Term, Definition table
TermDefinition
Brain biopsy procedure kitA packaged collection of sterile equipment that includes a disposable brain biopsy needle and other supplies used to perform a stereotaxic sampling of brain tissue. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933506164
Device count
1
Lot or batch
true
Expiration date on label
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
B887SHZ035020220VISICOIL MRSHZ-035-020-22SHZ-035-020-222022-07-18
B887SN035005PL200VISICOILSN-035-005-PL20SN-035-005-PL202022-07-18
B887SN035010PL200VISICOILSN-035-010-PL20SN-035-010-PL202022-07-18

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Primary DI, Brand, Company table
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07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
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