3D Anatomic Model

GUDID G003DM01

3D printed patient specific replicas of patient anatomy

Ricoh Usa, Inc.

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 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: G003DM01
• NIH Device Record Key: 007ffd87-3aa5-430a-b846-10fb64c86472
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Anatomic Model
• Version Model Number: 1
• Company DUNS: 043964519
• Company Name: Ricoh Usa, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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
HIBCC	G003DM01 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220205

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: 2022-08-02
• Device Publish Date: 2022-07-25