EmbedMed

GUDID 00860009815704

Patient-specific, Maxillofacial Anatomical Model, Non-sterile

3D LIFEPRINTS UK LTD

Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model

• Primary Device ID: 00860009815704
• NIH Device Record Key: 041665c4-9800-481c-b067-ce8adc64c926
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmbedMed
• Version Model Number: CMFAMNS
• Company DUNS: 220777297
• Company Name: 3D LIFEPRINTS UK LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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	00860009815704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220366

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: 2023-02-28
• Device Publish Date: 2023-02-20

On-Brand Devices [EmbedMed]

• 00860009815704: Patient-specific, Maxillofacial Anatomical Model, Non-sterile
• 00860009815773: Patient-specific, Orthopedic Anatomical Model, Non-sterile
• 00860009815766: Patient-specific, Orthopedic Anatomical Model, For End-user Sterilization
• 00860009815759: Patient-specific, Orthopedic Surgical Guide
• 00860009815742: Patient-specific, Othopedic Anatomical Model, Digital
• 00860009815735: Patient-specific, Maxillofacial Anatomical Model, Digital
• 00860009815728: Patient-specific, Maxillofacial Surgical Guide
• 00860009815711: Patient-specific, Maxillofacial Anatomical Model, For End-user Sterilization