ELEMENTS SMARTBRUSH 26200-02C

GUDID 04056481006877

Brainlab AG

Radiology picture archiving and communication system application software

• Primary Device ID: 04056481006877
• NIH Device Record Key: 038a422f-d531-4ebc-9a35-3e117e45f8af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEMENTS SMARTBRUSH
• Version Model Number: 2.5
• Catalog Number: 26200-02C
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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: true
• Serial Number: false
• 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	04056481006877 [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: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-12-23

On-Brand Devices [ELEMENTS SMARTBRUSH]

• 04056481006877: 2.5
• 04056481000431: 1