FDA.reportPublic FDA data

Evonos

Primary DI
04054462020911
Brand
Evonos
Company
evonos GmbH & Co. KG
Model
26-000006
Device description
evoDrill Cranial Perforator, Ø13/9mm, 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
04054462020911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462020911040544620209114054462020911

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
04054462156481evonosWT119400WT1194002026-08-26
04054462156498evonosWT524820WT5248202026-08-26
04054462156504evonosWT415000WT4150002026-08-26
04054462913039evonosWT415100WT4151002026-08-26
04054462913602evonosWT430432WT4304322026-08-25
04054462913619evonosWT430450WT4304502026-08-25
04054462913626evonosWT430452WT4304522026-08-25
04054462913633evonosWT432000WT4320002026-08-25
04054462913732evonosWT438512WT4385122026-08-25
04054462913763evonosWT438714WT4387142026-08-25
04054462913794evonosWT439000WT4390002026-08-25
04054462913824evonosWT439100WT4391002026-08-25
04054462913831evonosWT439200WT4392002026-08-25
04054462913855evonosWT440500WT4405002026-08-25
04054462913893evonosWT441500WT4415002026-08-25
04054462913909evonosWT442000WT4420002026-08-25
04054462913916evonosWT442100WT4421002026-08-25
04054462913923evonosWT442200WT4422002026-08-25
04054462913947evonosWT444000WT4440002026-08-25
04054462913978evonosWT445000WT4450002026-08-25

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
04054462020874Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020898Evonosevonos 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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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