Femoral Tibial C. Blk Adptr Kit Univ Ii 41888B

GUDID 04056481099985

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481099985
• NIH Device Record Key: fe719c1a-a016-45d2-bf63-49bc2c23124b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral Tibial C. Blk Adptr Kit Univ Ii
• Version Model Number: 41888B
• Catalog Number: 41888B
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481099985 [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

[04056481099985]

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 [Femoral Tibial C. Blk Adptr Kit Univ Ii]

• 04056481099985: 41888B
• 04056481002602: 41888A