Reference Headband (1Pc)

GUDID 04056481138516

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481138516
• NIH Device Record Key: 0612df5a-0e4e-4198-9f91-f546bb5a022f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reference Headband (1Pc)
• Version Model Number: 41876E
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	04056481138516 [Primary]
GS1	04056481138523 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092467

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

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: 2017-08-29

On-Brand Devices [Reference Headband (1Pc)]

• 04056481138516: 41876E
• 04056481131487: 41876D