Reusable guide

GUDID 03665134000790

The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access.

KOELIS

Needle guide, reusable

• Primary Device ID: 03665134000790
• NIH Device Record Key: f4c7db27-f955-4752-b60e-83725d80ba81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable guide
• Version Model Number: GPK-490
• 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
• Phone: +33458176811
• Email: qra@koelis.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Rigid container, padded. Store them in maximum hygienic conditions at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665134000790 [Primary]
GS1	03665134000820 [Package]; Package: Cardboard [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141334

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

[03665134000790]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2025-03-18
• Device Publish Date: 2020-07-17

On-Brand Devices [Reusable guide]

• 03665134000059: The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound prob
• 03665134000790: The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound prob