Template

GUDID 00860009784918

Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and 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: 00860009784918
• NIH Device Record Key: b4314817-d6c5-4f79-878c-80b6b227c1c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Template
• Version Model Number: MOST
• 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	00196852129638 [Previous]
GS1	00860009784918 [Primary]

FDA Product Code

• HWT: Template

Sterilization

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

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

Moist Heat or Steam Sterilization

[00860009784918]

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 [Template]

• 00196852129638: Patient specific, 3D printed, single use surgical marking template based a patient’s baseline
• 00860009784918: Patient specific, 3D printed, single use surgical marking template based a patient’s baseline