Myoma Drill

Myoma Drill
NA - 0250080134

A manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.

No Data Available

• Diameter: 10.0 Millimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: OCZ

Device Name: Endoscopic Grasping/Cutting Instrument, Non-Powered

Device Class: 2

Physical State: Non-electric and non-magnetic devices. May include: grasping or retrieval forceps, biopsy forceps or other sampling tools, scissors, stone basket, stone dislodger

Definition: To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Place through an endoscope to reach desired area.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various tissues, stones or other foreign bodies within GI and GU tract.

Regulation Number: 876.1500

Third Party Flag: Y

Medical Specialty: GU

Device Id: 07613327052237

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