ACTIVATION KEY, RIGID
NA - 62-00060
Device Description
A surgical instrument typically used in pairs to facilitate correct cranial orientation of craniofacial implants (e.g., fixation plates being attached to jaw bones) and other devices (e.g., craniofacial distractors) during their application in craniofacial surgery. It is typically designed as a long, thin, rigid rod made of high-grade stainless steel or titanium alloy with connectors at either end for attachment to the devices being aligned; it may have a knurled mid section (to provide better grip) onto which other instruments can be locked to assist the orientation procedure. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: LXH
Device Name: Orthopedic Manual Surgical Instrument
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: OR
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: 888.4540
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 07613252133704
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