HAND DRILL
NA - 0306813000
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 single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Needle Gauge: 13.0 Gauge
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OCJ
Device Name: Spinal Channeling Instrument, Vertebroplasty
Device Class: 1
Physical State: Composed of cannula for placement within the vertebral body and cutting element that is deployed by the surgeon once the cannula is placed.
Definition: Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.
Submission Type ID: 4
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Device placed within cancellous bone of vertebral body and then cutting element advanced forward out of device by surgeon to create channel for cement flow.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Vertebral body.
Regulation Number: 888.4540
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 37613327374446
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613327374445
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 07613327374445
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