DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE

GUDID 04056481141660

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

• Primary Device ID: 04056481141660
• NIH Device Record Key: e030f358-9b0b-4174-ab8b-1f06f132dae0
• Commercial Distribution Discontinuation: 2023-05-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE
• Version Model Number: 56101
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	04056481141660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202320

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-01-04
• Device Publish Date: 2023-01-11

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