FDA.reportPublic FDA data

Cranial trephine, single-use

Definition
A neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior, e.g., for the insertion of a catheter or a neuroscope for diagnosis, or treatments such as, to alleviate intracranial pressure (ICP), obtain cerebrospinal fluid samples, inject radiopaque dyes. It may be used to make several holes for the removal of a bone flap. It is typically a hollow cylinder with a circular, saw-like serrated working edge and a centre drill for guidance. It is an exchangeable device, typically made of high-grade stainless steel, that is attached to a manually rotated handle or to a powered rotary surgical handpiece. This is a single-use device.
GUDID devices
71
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B775110L0PHASORPHASOR HEALTH LLC11.0L2026-03-27
B775110S0PHASORPHASOR HEALTH LLC11.0S2026-03-27
B775140L0PHASORPHASOR HEALTH LLC14.0L2026-04-04
B775140S0PHASORPHASOR HEALTH LLC14.0S2026-04-04
B7752IN105CK0PHASORPHASOR HEALTH LLC2-IN-1-05CK2026-03-27
B7752IN125K0PHASORPHASOR HEALTH LLC2-IN-1-25K2025-11-23
B7752IN1260PHASORPHASOR HEALTH LLC2-IN-1-262026-03-28
B7752IN145CK0PHASORPHASOR HEALTH LLC2-IN-1-45CK2026-03-28
B7752IN145K0PHASORPHASOR HEALTH LLC2-IN-1-45K2025-11-23
B7753IN1245K0PHASORPHASOR HEALTH LLC3-IN-1-245K2026-03-27
B7753IN1256CK0PHASORPHASOR HEALTH LLC3-IN-1-256CK2026-03-28
B7753IN145RK0PHASORPHASOR HEALTH LLC3-IN-1-45RK2026-03-28
B7754IN12456K0PHASORPHASOR HEALTH LLC4-IN-1-2456K2026-03-28
B775840L0PHASORPHASOR HEALTH LLC8.40L2026-03-27
B775840S0PHASORPHASOR HEALTH LLC8.40S2026-03-27
B775PH53070PHK20PHASORPHASOR HEALTH LLCPH-530-70 + PH-K-22020-05-22
B775PH63570DPHK10PHASORPHASOR HEALTH LLCPH-635-70-D + PH-K-12020-05-20
B775PH63570DPHK20PHASORPHASOR HEALTH LLCPH-635-70-D + PH-K-22020-05-21
B775635CK0PHASORPHASOR HEALTH LLC6.35CK2026-01-19
B7752IN125LK0PHASORPHASOR HEALTH LLC2-IN-1-25LK2025-11-24
B7752IN126K0PHASORPHASOR HEALTH LLC2-IN-1-26K2025-11-24
B7752IN126LK0PHASORPHASOR HEALTH LLC2-IN-1-26LK2025-11-24
B7752IN145LK0PHASORPHASOR HEALTH LLC2-IN-1-45LK2025-11-24
B7753IN1246K0PHASORPHASOR HEALTH LLC3-IN-1-246K2025-11-24
B7753IN1246LK0PHASORPHASOR HEALTH LLC3-IN-1-246LK2025-11-24
B7753IN1256K0PHASORPHASOR HEALTH LLC3-IN-1-256K2025-11-24
B7753IN1256LK0PHASORPHASOR HEALTH LLC3-IN-1-256LK2025-11-24
B7754IN1K0PHASORPHASOR HEALTH LLC4-IN-1K2025-11-24
B7754IN1LK0PHASORPHASOR HEALTH LLC4-IN-1LK2025-11-24
B7755IN1LK0PHASORPHASOR HEALTH LLC5-IN-1LK2025-11-24
B775GREDBA0PHASORPHASOR HEALTH LLCGRE.DBA2025-11-24
B775GREDRI0PHASORPHASOR HEALTH LLCGRE.DRI2025-11-24
B775210L0PHASORPHASOR HEALTH LLC2.10L2024-11-08
B775PH45070DTPHKA1S0PHASORPHASOR HEALTH LLCPH-450-70-DT+PH-K-A1S2022-10-30
B775PH2402100PHASORPHASOR HEALTH LLCPH-240-2102020-05-21
B775PH240210PHK20PHASORPHASOR HEALTH LLCPH-240-210 + PH-K-22020-05-21
B775PH240700PHASORPHASOR HEALTH LLCPH-240-702020-05-21
B775PH2702100PHASORPHASOR HEALTH LLCPH-270-2102020-05-21
B775PH270700PHASORPHASOR HEALTH LLCPH-270-702020-05-21
B775PH27070PHK10PHASORPHASOR HEALTH LLCPH-270-70 + PH-K-12020-05-21
B775PH27070PHK20PHASORPHASOR HEALTH LLCPH-270-70 + PH-K-22020-05-21
B775PH3202100PHASORPHASOR HEALTH LLCPH-320-2102020-05-21
B775PH45070DPHK10PHASORPHASOR HEALTH LLCPH-450-70-D + PH-K-12020-05-22
B775PH45070PHK10PHASORPHASOR HEALTH LLCPH-450-70 + PH-K-12020-05-21
B775PH53070DPHK20PHASORPHASOR HEALTH LLCPH-530-70-D + PH-K-22020-05-21
B775PH580700PHASORPHASOR HEALTH LLCPH-580-702020-05-21
B775PH58070D0PHASORPHASOR HEALTH LLCPH-580-70-D2020-05-21
B775PH635700PHASORPHASOR HEALTH LLCPH-635-702020-05-21
B775PH63570D0PHASORPHASOR HEALTH LLCPH-635-70-D2020-05-21
B775PH63570PHK10PHASORPHASOR HEALTH LLCPH-635-70 + PH-K-12020-05-22
B775PH63570PHK20PHASORPHASOR HEALTH LLCPH-635-70 + PH-K-22020-05-22
B775PH45070DTPHKA10PHASORPHASOR HEALTH LLCPH-450-70-DT + PH-K-A12021-06-07
20886704005145CODMANCerenovus, Inc.26-12462016-06-30
00810607000019Disposable Cranial PerforatorACRA-CUT INC200-241 14/11mm2017-05-01
00810607000026Disposable Cranial PerforatorACRA-CUT INC200-243 11/7 mm2017-05-01
00810607000033Disposable Cranial PerforatorACRA-CUT INC200-245 13/9 mm2017-05-01
00810607000040Disposable Cranial PerforatorACRA-CUT INC200-251 14/11 mm2017-05-01
00810607000057Disposable Cranial PerforatorACRA-CUT INC200-253 11/7 mm2017-05-01
00810607000064Disposable Cranial PerforatorACRA-CUT INC200-255 13/9 mm2017-05-01
00810607000071Disposable Cranial PerforatorACRA-CUT INC200-271 14/11 mm2017-05-01
00810607000088Disposable Cranial PerforatorACRA-CUT INC200-275 13/9mm2017-05-01
00810607000095Disposable Cranial PerforatorACRA-CUT INC200-283 8/5 mm2017-05-01
00810607000101Disposable Cranial PerforatorACRA-CUT INC200-331 11/7 mm2017-05-01
00810607000118Disposable Cranial PerforatorACRA-CUT INC200-500 14/9 mm2017-05-01
00810607000125Disposable Cranial PerforatorACRA-CUT INC210-221 14/11 mm2017-05-01
00810607000385Cranial Blade Disposable Low SpeedACRA-CUT INC800-130 Single2017-05-01
00810607000392Cranial Blade Disposable low speedACRA-CUT INC800-1302017-05-01
00810607000408Cranial Blade Disposable low speedACRA-CUT INC800-140 Single2017-05-01
00810607000415Cranial Blade Disposable low speedACRA-CUT INC800-1402017-05-01
00810607000422Wire Pass DrillACRA-CUT INC800-330 Single2017-05-01
00810607000439Wire Pass DrillACRA-CUT INC800-3302017-05-01