Headpins 41561-1

GUDID 04056481004019

Brainlab AG

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 04056481004019
• NIH Device Record Key: 422d23a9-f57a-41dc-97d5-c6a38b3ba89c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headpins
• Version Model Number: 41561-1
• Catalog Number: 41561-1
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481004019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954789

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[04056481004019]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-31
• Device Publish Date: 2016-09-15

On-Brand Devices [Headpins]

• 04056481004033: 41560-0
• 04056481004026: 41560-1
• 04056481004019: 41561-1
• 04056481004002: 41561-2
• 04056481003999: 41561-3
• 04056481003982: 41561-4
• 04056481003975: 41561-5
• 04056481003968: 41561-6
• 04056481003951: 41561-7
• 04056481003944: 41561-8
• 04056481003937: 41562-1
• 04056481003920: 41562-2