Cirq Arm System 2.0

GUDID 04056481143961

Brainlab AG

Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted Surgical instrument assist arm system, power-adjusted

• Primary Device ID: 04056481143961
• NIH Device Record Key: 2bcdd8c6-2adf-4444-8050-832633e29d96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cirq Arm System 2.0
• Version Model Number: 56500
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481143961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222966

FDA Product Code

• HAW: Neurological Stereotaxic Instrument
• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-14
• Device Publish Date: 2022-11-04

Devices Manufactured by Brainlab AG

• 04056481144753 - Drill Guide Array: 2024-06-12
• 04056481144760 - Drill Guide Depth Control (60 - 100 mm): 2024-06-12
• 04056481144777 - Drill Guide Depth Control (0 - 60 mm): 2024-06-12
• 04056481144784 - Drill Guide Tube (4.5 mm): 2024-06-12
• 04056481144791 - Drill Guide Tube (3.2 mm): 2024-06-12
• 04056481144807 - Drill Guide Tube (2.6 mm): 2024-06-12
• 04056481144814 - Drill Guide Tube (2.4 mm): 2024-06-12
• 04056481144821 - Drill Guide Tube (2.0 mm): 2024-06-12