FDA.reportPublic FDA data

PHASOR

Primary DI
B7753IN1245K0
Brand
PHASOR
Company
PHASOR HEALTH LLC
Model
3-IN-1-245K
Device description
Phasor Cranial Access Kit, 3-IN-1-, with Electric Driver, quick-connect, with bit diameters 2.70-mm, 4.50-mm, 5.30-mm, with Kit (drug-containing)
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)
OJGNeurological Tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7753IN1245K0PrimaryHIBCC0

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
B775140L0PHASOR14.0L2026-04-04
B775140S0PHASOR14.0S2026-04-04
B775110L0PHASOR11.0L2026-03-27
B775110S0PHASOR11.0S2026-03-27
B7752IN105CK0PHASOR2-IN-1-05CK2026-03-27
B7752IN125LKX0PHASOR2-IN-1-25LKX2026-03-27
B7752IN1260PHASOR2-IN-1-262026-03-28
B7752IN145CK0PHASOR2-IN-1-45CK2026-03-28
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
B7754IN1LK0PHASOR4-IN-1LK2025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10809160527887HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527924HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527986HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160528013HalyardAVID MEDICAL, INC.OJG2026-07-28
10809160528037HalyardAVID MEDICAL, INC.OJG2026-07-28
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10198956534339CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956534353CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956537071CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27