FDA.reportPublic FDA data

Automatic cranial perforator, single-use

Definition
A 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.
GUDID devices
89
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05999860261001NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságNLO-11/14-3.02025-09-16
05999860261018NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságNLO-11/14-1.52025-09-16
05999860261025NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságNLO-7/11-3.02025-09-16
05999860261032NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságNLO-7/11-1.52025-09-16
05999860261049NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságNLO-6/9-3.02025-09-16
05999860261056NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságNLO-6/9-1.52025-09-16
05999860261230NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságNLO-9/13-3.02025-09-16
05999860261247NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságNLO-9/13-1.52025-09-16
07898959543050EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaDM0008FAA2016-08-19
07898959543067EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaDM0011FAA2016-08-19
07898959543074EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaDM0210FAA2016-08-19
07898959543081EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmMicromar Indústria e Comércio LtdaDM0010FAA2016-08-19
07898959543326EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaDM0008FAA2019-07-24
07898959543333EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmMicromar Indústria e Comércio LtdaDM0010FAA2019-07-24
07898959543340EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaDM0011FAA2019-07-24
07898959543357EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaDM0210FAA2019-07-24
B7752IN10PHASORPHASOR HEALTH LLC2-IN-12025-10-21
B7752IN1K0PHASORPHASOR HEALTH LLC2-IN-1K2025-10-22
B775450L0PHASORPHASOR HEALTH LLC4.50L2024-09-05
B7755IN10PHASORPHASOR HEALTH LLC5-IN-12024-12-15
B7755IN1K0PHASORPHASOR HEALTH LLC5-IN-1K2024-12-15
04054462020836Evonosevonos GmbH & Co. KG26-0000022024-04-25
04054462020850Evonosevonos GmbH & Co. KG26-0000032024-04-25
04054462020874Evonosevonos GmbH & Co. KG26-0000042024-04-25
04054462020898Evonosevonos GmbH & Co. KG26-0000052024-04-25
04054462020911Evonosevonos GmbH & Co. KG26-0000062024-04-25
04054462020935Evonosevonos GmbH & Co. KG26-0000072024-04-25
04054462020959Evonosevonos GmbH & Co. KG26-0000082024-04-25
04054462020973Evonosevonos GmbH & Co. KG26-0000092024-04-25
04054462122981Evonosevonos GmbH & Co. KG26-4141132024-04-25
04054462122998Evonosevonos GmbH & Co. KG26-4141112024-04-25
04054462123001Evonosevonos GmbH & Co. KG26-4130932024-04-25
04054462123018Evonosevonos GmbH & Co. KG26-4130912024-04-25
04054462123025Evonosevonos GmbH & Co. KG26-4110732024-04-25
04054462123032Evonosevonos GmbH & Co. KG26-411071 2024-04-25
04054462123049Evonosevonos GmbH & Co. KG26-4090632024-04-25
04054462123056Evonosevonos GmbH & Co. KG26-4090612024-04-25
07898959543593EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmMicromar Indústria e Comércio LtdaDM0010FAA2023-10-30
07898959543609EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaDM0210FAA2023-10-30
07898959543616EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaDM0011FAA2023-10-30
07898959543623EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaDM0008FAA2023-10-30
B775240L0PHASORPHASOR HEALTH LLC2.40L2023-02-20
B775240S0PHASORPHASOR HEALTH LLC2.40S2023-02-20
B775270L0PHASORPHASOR HEALTH LLC2.70L2023-02-20
B775270S0PHASORPHASOR HEALTH LLC2.70S2023-02-20
B775320L0PHASORPHASOR HEALTH LLC3.20L2023-02-20
B7754500PHASORPHASOR HEALTH LLC4.502023-02-20
B7755300PHASORPHASOR HEALTH LLC5.302023-02-20
B7755800PHASORPHASOR HEALTH LLC5.802023-02-20
B7756350PHASORPHASOR HEALTH LLC6.352023-02-20
B775450K0PHASORPHASOR HEALTH LLC4.50K2023-02-16
07898959543555EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaDM0008FAA2022-12-02
07898959543562EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaDM0011FAA2022-12-02
07898959543579EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaDM0210FAA2022-12-02
07898959543586EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmMicromar Indústria e Comércio LtdaDM0010FAA2022-12-02
07898959543470EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmMicromar Indústria e Comércio LtdaDM0010FAA2022-05-23
07898959543487EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaDM0210FAA2022-05-23
07898959543494EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaDM0011FAA2022-05-23
07898959543500EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaDM0008FAA2022-05-23
10886704005100CODMANCerenovus, Inc.26-12212016-06-30
10886704005117CODMANCerenovus, Inc.26-12222016-06-30
10886704005124CODMANCerenovus, Inc.26-12232016-06-30
EADEPER1114S1Meridian Perforatoradeor Medical AGalpha2017-02-11
EADEPER1114SG1Meridian Perforatoradeor Medical AGalpha2017-02-11
EADEPER1114SP1Meridian Perforatoradeor Medical AGalpha2017-02-11
EADEPER711S1Meridian Perforatoradeor Medical AGalpha2017-02-11
EADEPER711SP1Meridian Perforatoradeor Medical AGalpha2017-02-11
EADEPERC1114S1Meridian Perforatoradeor Medical AGClassic2017-02-11
EADEPERC69S1Meridian Perforatoradeor Medical AGClassic2017-02-11
EADEPERC811S1Meridian Perforatoradeor Medical AGClassic2017-02-11
10381780513599CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION2612212020-04-01
10381780513605CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION2612222020-04-01
10381780513612CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATION2612232020-04-01
07898959543166EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaDM0008FAA2020-03-31
07898959543173EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaDM0011FAA2020-03-31
07898959543180EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaDM0210FAA2020-03-31
07898959543197EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmMicromar Indústria e Comércio LtdaDM0010FAA2020-03-31
04546540716224ZyphrSTRYKER CORPORATION51000600012016-09-23
00810607002006ACRA-CUTACRA-CUT INC14/9mm SDR (SMARTdrill)2016-09-23
00810607002211ACRA-CUTACRA-CUT INC14/11mm CDM2016-09-23