FJ2000 System P65-001-0006-SK

GUDID 00889795131140

FJ-2000, MIS Irrigation Kit (Sterile)

PARAGON 28, INC.

Surgical power tool system control unit, line-powered

• Primary Device ID: 00889795131140
• NIH Device Record Key: 0c28485b-b337-4364-8863-5c894823fab7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FJ2000 System
• Version Model Number: P65-001-0006-SK
• Catalog Number: P65-001-0006-SK
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795131140 [Primary]

FDA Product Code

• HAB: SAW, POWERED, AND ACCESSORIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-02
• Device Publish Date: 2023-10-25

On-Brand Devices [FJ2000 System]

• 00889795133113: Shannon-style Recta Bone Burr, 3.0 x 30 x 100, AO (Sterile)
• 00889795133106: Shannon-style Corta Bone Burr, 3.0 x 20 x 100, AO (Sterile)
• 00889795133090: Shannon-style Corta Bone Burr, 2.0 x 20 x 72 AO (sterile)
• 00889795131287: Shannon-style Recta Bone Burr, 2.2 x 20 x 100, AO (Sterile)
• 00889795131270: FJ-2000, Screw for Foot Hook
• 00889795131263: FJ-2000, Foot Hook
• 00889795131256: FJ-2000, Hardware for Fluid Bag
• 00889795131225: FJ-2000, Power Cord US Version 100V
• 00889795131218: FJ-2000, Foot Pedal
• 00889795131201: FJ-2000, Power Console with Irrigation Pump
• 00889795131195: FJ-2000, Minimally Invasive Procedure and Open Kit (Sterile)
• 00889795131188: Saw Blade, 9 x 31 x .051mm, OrthoCircle (Sterile)
• 00889795131171: FJ-2000, Open Procedure with Sagittal Saw Kit (Sterile)
• 00889795131164: FJ-2000, High Speed Handpiece with Sagittal Saw Kit (Sterile)
• 00889795131157: FJ-2000, MIS Instrument Kit (Sterile)
• 00889795131140: FJ-2000, MIS Irrigation Kit (Sterile)
• 00889795131133: Wedge Bone Burr, 4.3 x 13 x 72, AO (Sterile)
• 00889795131126: Wedge Bone Burr, 2.9 x 13 x 72, AO (Sterile)
• 00889795131119: Shannon-style Recta Bone Burr, 3.0 x 30 x 82, AO (Sterile)
• 00889795131102: Shannon-style Recta Bone Burr, 2.2 x 20 x 82, AO (Sterile)
• 00889795131096: Shannon-style Recta Bone Burr, 2.2 x 20 x 72, AO (Sterile)
• 00889795131089: Shannon-style Recta Bone Burr, 2.0 x 20 x 72, AO (Sterile)
• 00889795131072: Shannon-style Recta Bone Burr, 2.0 x 13 x 72, AO (Sterile)
• 00889795131065: Shannon-style Corta Bone Burr, 2.0 x 8 x 72, AO (Sterile)
• 00889795131058: FJ-2000, Minimally Invasive Procedure Kit for Hardware (Sterile)
• 00889795131041: FJ-2000, MIS Hand Piece and AO Connection Kit (Sterile)