Carbide Round

Carbide Round
N/A - 5820110030C

A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.

No Data Available

• Diameter: 3.0 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: HBE

Device Name: Drills, Burrs, Trephines & Accessories (Simple, Powered)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 882.4310

Third Party Flag: Y

Medical Specialty: NE

Code: OLO

Device Name: Orthopedic Stereotaxic Instrument

Device Class: 2

Physical State: Device consists of Camera, computer, various shaped tracking arrays, computer interface for commmunication between user and device.

Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: User loads Computer software pre-Op to plan surgery procedure, then registers the patient anatomy during surgery to allow software to track patient anatomy, implants, and surgical tools in real time/space.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Orthopedic joints and spinal procedures where tracking of instrumentation is desired.

Regulation Number: 882.4560

Third Party Flag: N

Medical Specialty: NE

Device Id: 07613327294842

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A