Legato®

GUDID 04250337103813

Legato® Hand Piece, bipolar

Joimax GmbH

Radio-frequency ablation system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

• Primary Device ID: 04250337103813
• NIH Device Record Key: a8be8770-46b4-4939-9e46-a7a4be05ca26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legato®
• Version Model Number: JBPH352505
• Company DUNS: 344267187
• Company Name: Joimax GmbH
• 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: 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

Customer Support Contacts

• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com
• Phone: +49721255140
• Email: quality@joimax.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250337103813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161378

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

[04250337103813]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-08

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• 04250337104070: Legato® Hand Piece, monopolar
• 04250337103820: Legato® Hand Piece, bipolar
• 04250337103776: Legato® Hand Piece, monopolar
• 04250337103769: Legato® handpiece, mono / L=3,5 m cable