THALES 3D SCANNER 0016164-0002

GUDID 04260590372338

L A P GMBH LASER APPLIKATIONEN

Multi-modality therapeutic radiation phantom, test object

• Primary Device ID: 04260590372338
• NIH Device Record Key: bffe026e-0dfd-435a-8a6a-8a21946f8540
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THALES 3D SCANNER
• Version Model Number: Water Phantom Conv.
• Catalog Number: 0016164-0002
• Company DUNS: 313586582
• Company Name: L A P GMBH LASER APPLIKATIONEN
• 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: true
• Manufacturing Date: false
• 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	04260590372338 [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: 2021-07-27
• Device Publish Date: 2021-07-19

On-Brand Devices [THALES 3D SCANNER]

• 04260590372345: Carriage System
• 04260590372338: Water Phantom Conv.
• 04260590372383: Carriage System Conv.
• 04260590372376: Thales Phantom Conv.