Phasor Drill

Primary DI
M710008102804
Brand
Phasor Drill
Company
BIOTEX, INC.
Model
1
Published
2017-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M710008102804PrimaryHIBCC0

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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
713-741-0111xxx@xx.xx

Regulatory Flags#

DUNS number
969792050
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

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