Treatment Plan Rhinoplasty Model

GUDID 00860008704160

Patient-specific, partial-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.

Mirrorme3d, LLC

Custom-made organ/bone anatomy model

• Primary Device ID: 00860008704160
• NIH Device Record Key: a8f2f92d-18f1-431b-81d4-c858988ae884
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Treatment Plan Rhinoplasty Model
• Version Model Number: MRCS
• Company DUNS: 060396278
• Company Name: Mirrorme3d, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• 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	00860008704160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212981

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-11
• Device Publish Date: 2022-10-03

Devices Manufactured by Mirrorme3d, LLC

• 00860009784925 - Flap Marking Template: 2023-03-27 Patient specific, 3D printed, single use surgical flap marking template based a patient’s baseline status and treatment plan.
• 00860009784901 - Guide: 2023-02-24 Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnost
• 00860009784918 - Template: 2023-02-24 Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX o
• 00196852129638 - Template: 2022-10-11 Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX o
• 00196852441754 - Guide: 2022-10-11 Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnost
• 00860008704139 - Full Face Baseline Model: 2022-10-11 Patient-specific, full-face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. R
• 00860008704146 - Full Face Sim Model: 2022-10-11 Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.
• 00860008704153 - Baseline Rhinoplasty Model: 2022-10-11 Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic