3D-SHAPER

GUDID 08437021740028

3D-SHAPER MEDICAL S.L.

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