FDA.reportPublic FDA data

PHASOR

Primary DI
B7752IN105CK0
Brand
PHASOR
Company
PHASOR HEALTH LLC
Model
2-IN-1-05CK
Device description
Phasor Cranial Access Kit, includes both Electric and Manual Drivers, quick-connect, with bit diameters 4.80-mm and 5.30-mm diameter, with drug-containing Kit
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
HBGDrills, Burrs, Trephines & Accessories (Manual)
OJGNeurological Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7752IN105CK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cranial trephine, single-useA 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.

Regulatory Flags#

DUNS number
111926675
Device count
1
Kit
true
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
B775EZFIDUCIALS0PHASOREZ-FIDUCIALSEZ-FIDUCIALS2025-08-21
B775140L0PHASOR14.0L2026-04-04
B775140S0PHASOR14.0S2026-04-04
B775110L0PHASOR11.0L2026-03-27
B775110S0PHASOR11.0S2026-03-27
B7752IN125LKX0PHASOR2-IN-1-25LKX2026-03-27
B7752IN1260PHASOR2-IN-1-262026-03-28
B7752IN145CK0PHASOR2-IN-1-45CK2026-03-28
B7753IN1245K0PHASOR3-IN-1-245K2026-03-27
B7753IN1256CK0PHASOR3-IN-1-256CK2026-03-28
B7753IN145RK0PHASOR3-IN-1-45RK2026-03-28
B7754IN12456K0PHASOR4-IN-1-2456K2026-03-28
B775840L0PHASOR8.40L2026-03-27
B775840S0PHASOR8.40S2026-03-27
B775635CK0PHASOR6.35CK2026-01-19
B7752IN125LK0PHASOR2-IN-1-25LK2025-11-24
B7752IN126LK0PHASOR2-IN-1-26LK2025-11-24
B7752IN145LK0PHASOR2-IN-1-45LK2025-11-24
B7753IN1246LK0PHASOR3-IN-1-246LK2025-11-24
B7753IN1256LK0PHASOR3-IN-1-256LK2025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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