Myoma Drill
NA - 0250080133
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
- Diameter: 5.0 Millimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
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 IdentifiersDevice Id: 07613327052220
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