Steady Pro

GUDID 03665134000783

Probe holder for transrectal approach

KOELIS

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

• Primary Device ID: 03665134000783
• NIH Device Record Key: 11f7be96-dddf-43f1-8f8e-9cf088ad98b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steady Pro
• Version Model Number: KSP.SUPP.TR
• Company DUNS: 290318455
• Company Name: KOELIS
• 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: 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

Customer Support Contacts

• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com
• Phone: +33458176811
• Email: qra@koelis.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665134000776 [Primary]
GS1	03665134000783 [Package]; Contains: 03665134000776; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171040

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

[03665134000783]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [Steady Pro]

• 03665134000592: Steady Pro (Mechanical probe holder and supports) The steady pro range is intended to reliably m
• 03665134000806: Universal clamping base The steady pro range is intended to reliably maintain the position of a
• 03665134000783: Probe holder for transrectal approach
• 03665134000745: Probe holder for transperineal approach. The steady pro range is intended to reliably maintain t
• 03665134000738: Steady Pro Probe Holding Arm with I and U extension and rail clamping base The Steady Pro range