Guide

GUDID 00860009784901

Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnostic.

Mirrorme3d, LLC

Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00860009784901
• NIH Device Record Key: 0e739c87-0127-4b46-97dc-0b440c9a4a0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide
• Version Model Number: MTPG
• Company DUNS: 060396278
• Company Name: Mirrorme3d, LLC
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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	00196852441754 [Previous]
GS1	00860009784901 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

[00860009784901]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-24
• Device Publish Date: 2023-02-16

On-Brand Devices [Guide]

• 00196852441754: Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treat
• 00860009784901: Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treat