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LITe - FC-110-22-B-2
Device Description
A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 559.0 Millimeter
- Diameter: 1.1 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
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: 37613327343442
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613327343441
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: pack
Device Id: 07613327343441
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