FDA.reportPublic FDA data

NeuroLine

Primary DI
05999860261049
Brand
NeuroLine
Company
EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság
Model
NLO-6/9-3.0
Catalog number
NLO-6/9-3.0
Device description
Disposable Cranial Perforator
Published
2025-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213228000NeuroLine Disposable Cranial Perforator with Hudson endEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.2022-06-20HBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05999860261049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05999860261049059998602610495999860261049

GMDN Terms#

Term, Definition table
TermDefinition
Automatic cranial perforator, single-useA sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. This is a single-use device.

Regulatory Flags#

DUNS number
401383419
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05999860261001NeuroLineNLO-11/14-3.0NLO-11/14-3.02025-09-16
05999860261018NeuroLineNLO-11/14-1.5NLO-11/14-1.52025-09-16
05999860261025NeuroLineNLO-7/11-3.0NLO-7/11-3.02025-09-16
05999860261032NeuroLineNLO-7/11-1.5NLO-7/11-1.52025-09-16
05999860261056NeuroLineNLO-6/9-1.5NLO-6/9-1.52025-09-16
05999860261230NeuroLineNLO-9/13-3.0NLO-9/13-3.02025-09-16
05999860261247NeuroLineNLO-9/13-1.5NLO-9/13-1.52025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05999860261001NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261018NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261025NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261032NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261056NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261230NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261247NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
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04054462020935Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020959Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020973Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462122981Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462122998Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123001Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123018Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123025Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123032Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123049Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123056Evonosevonos GmbH & Co. KGHBF2024-04-25
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07898959543616EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543623EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543555EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaHBF2022-12-02
07898959543562EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaHBF2022-12-02
07898959543579EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaHBF2022-12-02