11G HAND DRILL PACK

11G HAND DRILL PACK
OptaBlate - 9700811000

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.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 37613327591553

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327591552

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 07613327591552

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

Device Id: 57613327591557

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 37613327591553

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: case