Digital Lightbox® 54200B

GUDID 04056481001797

Brainlab AG

Radiology picture archiving and communication system workstation

• Primary Device ID: 04056481001797
• NIH Device Record Key: c8f5a37d-7087-45b2-ab82-832b403810ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Lightbox®
• Version Model Number: 54200B
• Catalog Number: 54200B
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49899915680
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481001797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093117

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

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• 04056481144913 - CRANIAL 4PI STEREOTACTIC MASK (5 PCS.): 2024-07-26
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• 04056481144937 - CRANIAL 4PI BASIC MASK (5 PCS.): 2024-07-26
• 04056481144944 - CRANIAL 4PI BASIC MASK (1 PC.): 2024-07-26
• 04056481144951 - CRANIAL 4PI OPEN FACE MASK (5 PCS.): 2024-07-26