FDA.reportPublic FDA data

PHASOR

Primary DI
B775635CK0
Brand
PHASOR
Company
PHASOR HEALTH LLC
Model
6.35CK
Device description
Phasor Cranial Access Kit, with Phasor Drill quick-connect, 6.35-mm Bit, with Phasor Legacy manual drill and Phasor electric Drill, with Kit
Published
2026-01-19
Public version status
Update
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
B775635CK0PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111926675
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
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
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
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
10809160530696HalyardAVID MEDICAL, INC.OJG2026-08-19
10809160530757HalyardAVID MEDICAL, INC.OJG2026-08-19
10809160530764HalyardAVID MEDICAL, INC.OJG2026-08-19
10809160530832HalyardAVID MEDICAL, INC.OJG2026-08-19
10198956469990CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956554825CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956556300CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956556317CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956557697CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10809160530269HalyardAVID MEDICAL, INC.OJG2026-08-18
10809160530559HalyardAVID MEDICAL, INC.OJG2026-08-18
10198956533899CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956535961CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956544581CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956548756CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956553231CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10809160528396HalyardAVID MEDICAL, INC.OJG2026-08-03
10809160528587HalyardAVID MEDICAL, INC.OJG2026-08-03
10198956327603CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956353961CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956504936CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956506947CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956513570CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956521346CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956524125CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956531130CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534131CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534674CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956538672CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956542297CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31