LUNA 3D 0018364-0009

GUDID 04260590372598

L A P GMBH LASER APPLIKATIONEN

Radiological video camera patient positioning/tracking system

• Primary Device ID: 04260590372598
• NIH Device Record Key: 5c57e965-f345-446e-bd2a-e4c877dff3f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUNA 3D
• Version Model Number: LUNA Distribution Box
• Catalog Number: 0018364-0009
• 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	04260590372598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232031

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: 2024-06-25
• Device Publish Date: 2024-06-17

On-Brand Devices [LUNA 3D]

• 04260590372673: LUNA 3D Central Server Software
• 04260590372666: LUNA 3D Workstation Software
• 04260590372659: Central Server host PC Luna 3D
• 04260590372642: LUNA SGRT PC
• 04260590372635: LUNA SGRT PC
• 04260590372628: LUNA 3D Central Server Software
• 04260590372611: LUNA 3D Workstation Software
• 04260590372604: LUNA Camera Pod
• 04260590372598: LUNA Distribution Box
• 04260590372581: LUNA Distribution Box
• 04260590372680: LUNA Camera Pod