Rocket R57525-00-T3

GUDID 05055270988645

Needle Guide

ROCKET MEDICAL PLC

Needle guide, single-use

• Primary Device ID: 05055270988645
• NIH Device Record Key: 1a90cb4f-204b-4da8-abbb-ab93ce4ebcbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rocket
• Version Model Number: R57525-00-T3
• Catalog Number: R57525-00-T3
• 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: true
• 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	05055270988638 [Primary]
GS1	05055270988645 [Package]; Contains: 05055270988638; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	05055270988652 [Package]; Package: Outer Carton [2 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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• 05055270973443: Rocket IPC DRessing Pack & Bag
• 05055270973412: Rocket IPC Peritoneal Insertion Set
• 05055270973382: Rocket IPC Mini Dressing Pack & Bag
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• 05055270972521: Rocket IPC Peritoneal MINI Insertion Set
• 05055270972491: Rocket IPC Peritoneal Insertion Set
• 05055270972460: Rocket IPC DIscharge Pack
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• 05055270971654: Rocket IPC Mini Dressing Pack & Bottle
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• 05055270971258: Rocket DIsposable Needle Guide
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• 05055270966438: Rocket 20Fg Seldinger Chest Drainage Kit
• 05055270966407: Rocket 28Fg Blunt DIssection Kit
• 05055270966377: Rocket 12Fg Seldinger Chest Drainage Kit
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• 05055270966254: Rocket 18Fg Seldinger Chest Drainage Kit
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• 05055270966063: Rocket DIsposable Needle Guide
• 05055270966032: Rocket DIsposable Needle Guide
• 05055270965929: Rocket IPC DIscharge Pack
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• 05055270965868: Rocket IPC 600ml Drainage Bottle
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• 05055270965806: Rocket IPC Insertion Set
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• 05055270965745: Rocket IPC Pleural Insertion Set
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• 05055270964656: Rocket Seldinger Catheter Fixation Set
• 05055270965257: Rocket BLUE Needle Drain Procedure Tray
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• 05055270964717: Rocket Seldinger Fixation Set
• 05055270964625: Rocket DIsposable Needle Guide