Adj Cutb - Fem Align Guide 53212

GUDID 04056481005580

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481005580
• NIH Device Record Key: 477834d5-6af4-49e5-8c18-a30200360c59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adj Cutb - Fem Align Guide
• Version Model Number: 53212
• Catalog Number: 53212
• 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	04056481005580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102990

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481005580]

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

On-Brand Devices [Adj Cutb - Fem Align Guide]

• 04056481005580: 53212
• 04056481001834: 53212A