Cirq Robotic Depth Tracking Array beige 56304

GUDID 04056481141264

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481141264
• NIH Device Record Key: 1615989d-128e-4695-bcfc-ba5486d19158
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cirq Robotic Depth Tracking Array beige
• Version Model Number: 56304
• Catalog Number: 56304
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481141264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202320

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

[04056481141264]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-18
• Device Publish Date: 2022-12-27

Devices Manufactured by Brainlab AG

• 04056481146221 - Quentry.com (Quentry Web) Quentry Gateway Quentry Desktop: 2024-04-15
• 04056481141660 - DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE: 2024-01-04
• 04056481144845 - Automatic Registration iMRI: 2023-11-28 Automatic Registration iMRI provides an automatic image registration for cranial indications.
• 04056481145606 - HEX SCREWDRIVER T-HANDLE (2.5 MM): 2023-10-27
• 04056481145217 - DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS): 2023-10-25
• 04056481145392 - DRAPELINK REF ADAPTER AUTO-REG IMRI: 2023-10-24
• 04056481145101 - Automatic Registration: 2023-10-02 Trade names: AUTO-REGISTRATION SOFTWARE AIRO CRANIAL, AUTO-REGISTRATION SOFTWARE AIRO CMF, AUTO-REGISTRATION SOFTWARE LOOP-X CRA
• 04056481143138 - Drill Bit Cranial 2.4/4.0: 2023-09-26