THALES 3D MR SCANNER 0016164-0001

GUDID 04260590372352

L A P GMBH LASER APPLIKATIONEN

Multi-modality therapeutic radiation phantom, test object

• Primary Device ID: 04260590372352
• NIH Device Record Key: e700d73f-d4c2-4d19-ae61-1518741740f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THALES 3D MR SCANNER
• Version Model Number: Thales Phantom 0,35T
• Catalog Number: 0016164-0001
• Company DUNS: 313586582
• Company Name: L A P GMBH LASER APPLIKATIONEN
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260590372352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200907

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2021-09-27
• Device Publish Date: 2021-09-17

On-Brand Devices [THALES 3D MR SCANNER]

• 04260590370754: Carriage System
• 04260590370747: Water Phantom
• 04260590372369: Carriage System 0,35T
• 04260590372352: Thales Phantom 0,35T