MIS MoRe™ Rod

GUDID 00811638036176

Ø4.5 X 55mm MoRe™ MIS Pre-Lordosed Rod, Sterile

MIRUS LLC

Bone-screw internal spinal fixation system rod

• Primary Device ID: 00811638036176
• NIH Device Record Key: b1193469-200d-4633-992c-c3dedec2066c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIS MoRe™ Rod
• Version Model Number: 1-54-4555
• Company DUNS: 080311078
• Company Name: MIRUS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00811638036176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180337

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-31
• Device Publish Date: 2023-01-24

On-Brand Devices [MIS MoRe™ Rod]

• 00811638036305: Ø4.5 X 120mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036299: Ø4.5 X 115mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036282: Ø4.5 X 110mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036275: Ø4.5 X 105mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036268: Ø4.5 X 100mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036251: Ø4.5 X 95mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036244: Ø4.5 X 90mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036237: Ø4.5 X 85mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036220: Ø4.5 X 80mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036213: Ø4.5 X 75mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036206: Ø4.5 X 70mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036190: Ø4.5 X 65mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036183: Ø4.5 X 60mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036176: Ø4.5 X 55mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036169: Ø4.5 X 50mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036152: Ø4.5 X 45mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036145: Ø4.5 X 40mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036138: Ø4.5 X 35mm MoRe™ MIS Pre-Lordosed Rod, Sterile
• 00811638036121: Ø4.5 X 30mm MoRe™ MIS Pre-Lordosed Rod, Sterile