FDA.reportPublic FDA data

PHASOR

Primary DI
B775PH635DT0
Brand
PHASOR
Company
PHASOR HEALTH LLC
Model
PH-635-70-DT
Catalog number
PH-635-70-DT
Device description
Phasor Drill, 6.35-mm diameter, with Drill Stop Extension (tapered)
Published
2021-06-07
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)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161704000Phasor DrillBiotex, Inc.2016-12-01HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B775PH635DT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Craniotomy power tool system, battery-powered, single-useA dedicated battery-powered assembly of devices intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)]; it may also be used for the removal of a bone flap for brain surgery. It typically consists of a handpiece containing a motor (engine), a battery-pack, an attachment with a clutch system that disengages the cutting tool when the inner table has been penetrated preventing injury to the brain, and an exchangeable rotating cutting tool (e.g., a cranial drill bit, bur, trephine or perforator). 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
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
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBE2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBE2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAHBE2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAHBE2025-03-20
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAHBE2023-02-22
07630055507792Cable for Perforator MotorBien-Air Surgery SAHBE2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAHBE2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055505804Cranio Guard 15mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505811Cranio Guard 10mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505835Cranio Guard 25mm fixBien-Air Surgery SAHBE2023-02-10
07630055505842RAPIDO MicromotorBien-Air Surgery SAHBE2023-02-10
07630055505866Cranio Guard 10mm fixBien-Air Surgery SAHBE2023-02-10
07630055505873Cranio Guard 15mm fixBien-Air Surgery SAHBE2023-02-10
07630055505910PM2-S125Bien-Air Surgery SAHBE2023-02-10
07630055505927PM2-S150Bien-Air Surgery SAHBE2023-02-10
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAHBE2023-02-09
07630055505699PM2-S70Bien-Air Surgery SAHBE2023-02-09
07630055505705PM2-A95Bien-Air Surgery SAHBE2023-02-09
07630055505712PM2-A125Bien-Air Surgery SAHBE2023-02-09
07630055505729NANO MicromotorBien-Air Surgery SAHBE2023-02-09
07630055505750PM2-A70HDBien-Air Surgery SAHBE2023-02-09
07630055505767PM2-S70HDBien-Air Surgery SAHBE2023-02-09