Rocket R57525-00-ME

GUDID 05055270988553

Needle Guide

ROCKET MEDICAL PLC

Needle guide, single-use

• Primary Device ID: 05055270988553
• NIH Device Record Key: 01329d36-569c-4dac-8e01-850bf9cfaa06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rocket
• Version Model Number: R57525-00-ME
• Catalog Number: R57525-00-ME
• Company DUNS: 544313588
• Company Name: ROCKET MEDICAL PLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055270988546 [Primary]
GS1	05055270988553 [Package]; Contains: 05055270988546; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	05055270988560 [Package]; Package: Outer Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032015

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-01
• Device Publish Date: 2023-10-24

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