NAIL range

GUDID 03665134000325

the device Nail.14 is used to guide linear instruments such as needle during, for example, ultrasound guided biopsy procedure. The nail.14 is compatible with needles from 14 to 16 gauge. The device is reusable but must be sterilized before use. The device is not provided in sterile condition.

KOELIS

Needle guide, reusable

• Primary Device ID: 03665134000325
• NIH Device Record Key: 92598f13-389e-4f68-8d74-75f7f7579cd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAIL range
• Version Model Number: NAIL.14
• Company DUNS: 290318455
• Company Name: KOELIS
• Device Count: 1
• DM Exempt: true
• 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: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com
• Phone: +33(0)458176810
• Email: qra@koelis.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665134000165 [Primary]
GS1	03665134000325 [Package]; Contains: 03665134000165; Package: [30 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

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

[03665134000325]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-12
• Device Publish Date: 2023-04-04

On-Brand Devices [NAIL range]

• 03665134000325: the device Nail.14 is used to guide linear instruments such as needle during, for example, ultra
• 03665134000158: Nails are used to guide linear instruments such as needles for application such as ultrasound bi