Igs Handle Softgrip 'Universal' 55830-15

GUDID 04056481001285

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481001285
• NIH Device Record Key: 3d3f721d-6dfa-4dd4-b344-23af4b033049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Igs Handle Softgrip 'Universal'
• Version Model Number: 55830-15
• Catalog Number: 55830-15
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481001285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070106

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[04056481001285]

Moist Heat or Steam Sterilization

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