- Physicians Office Resource

Zyphr Disposable Cranial Perforator, Large 14/11mm
Zyphr - 5100060001

Device Description

A sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Lumen/Inner Diameter: 11.0 Millimeter

Outer Diameter: 14.0 Millimeter

Lumen/Inner Diameter: 11.0 Millimeter
Outer Diameter: 14.0 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: HBF

Device Name: Drills, Burrs, Trephines & Accessories (Compound, 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: 882.4305

Third Party Flag: Y

Medical Specialty: NE

Device Identifiers

Device Id: 04546540716224

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

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