3D-SHAPER

GUDID 08437021740028

3D-SHAPER MEDICAL S.L.

Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system

• Primary Device ID: 08437021740028
• NIH Device Record Key: 5da366fb-d416-4341-a6bf-e8a749f653cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D-SHAPER
• Version Model Number: 2.11
• Company DUNS: 469850658
• Company Name: 3D-SHAPER MEDICAL S.L.
• 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: false
• Lot Batch: false
• Serial Number: false
• 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
GS1	08437021740028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220822

FDA Product Code

• KGI: Densitometer, Bone

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: 2023-10-12
• Device Publish Date: 2023-10-04