Legato®

GUDID 04250337103813

Legato® Hand Piece, bipolar

Joimax GmbH

Radio-frequency ablation 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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• 04250337115243: Legato® Probe monopolar, Ball Tip, straight
• 04250337103813: Legato® Hand Piece, bipolar
• 04250337103806: Legato® Probe bipolar, Ball Tip
• 04250337103783: Legato® Hand Piece, monopolar
• 04250337103752: Legato® Probe monopolar, Ball Tip
• 04250337119999: joimax® Legato-Trigger Flex
• 04250337104070: Legato® Hand Piece, monopolar
• 04250337103820: Legato® Hand Piece, bipolar
• 04250337103776: Legato® Hand Piece, monopolar
• 04250337103769: Legato® handpiece, mono / L=3,5 m cable