FDA.reportPublic FDA data

Evonos

Primary DI
04054462020874
Brand
Evonos
Company
evonos GmbH & Co. KG
Model
26-000004
Device description
evoDrill Cranial Perforator, Ø11/7mm, ab 1mm, 3 Flute
Published
2024-04-25
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
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054462020874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462020874040544620208744054462020874

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342657915
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
04054462122974evonos48-0000212025-07-25
04054462150489evonos48-0000352025-07-25
04054462150717evonos48-0000362025-07-25
04054462150724evonos48-0000372025-07-25
04054462150731evonos48-0000382025-07-25
04054462150748evonos48-0000392025-07-25
04054462150755evonos48-0000402025-07-25
04054462150762evonos48-0000412025-07-25
04054462151059evonos48-0000752025-07-25
04054462151066evonos48-0001142025-07-25
04054462151073evonos48-0001152025-07-25
04054462151080evonos48-0001162025-07-25
04054462151097evonos48-0001182025-07-25
04054462151103evonos48-0001192025-07-25
04054462151110evonos48-0001202025-07-25
04054462151127evonos48-0001212025-07-25
04054462151134evonos48-0001352025-07-25
04054462151141evonos48-0001362025-07-25
04054462151158evonos48-0001372025-07-25
04054462151165evonos48-0001382025-07-25

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
05999860261049NeuroLineEMD 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
04054462020836Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020850Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020898Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020911Evonosevonos GmbH & Co. KGHBF2024-04-25
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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07898959543609EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaHBF2023-10-30
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