Rocket R57585-SX-90

GUDID 05055270935519

Rocket SX Needle 17G x 90cm T Set

ROCKET MEDICAL PLC

IVF oocyte aspiration needle, single-use

• Primary Device ID: 05055270935519
• NIH Device Record Key: 65beaff0-89bc-4874-b492-67555018df72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rocket
• Version Model Number: R57585-SX-90
• Catalog Number: R57585-SX-90
• Company DUNS: 544313588
• Company Name: ROCKET MEDICAL PLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +4401914196988
• Email: gudid@rocketmedical.com

Device Dimensions

• Outer Diameter: 1.473 Millimeter
• Length: 32 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 101 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 101 KiloPascal and 101 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055270914125 [Primary]
GS1	05055270935519 [Package]; Contains: 05055270914125; Package: [10 Units]; In Commercial Distribution
GS1	05055270956910 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994327

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-08

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• 05055270971258: Rocket DIsposable Needle Guide
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• 05055270966032: Rocket DIsposable Needle Guide
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• 05055270965899: Rocket IPC Mini Dressing Pack & Bottle
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• 05055270965745: Rocket IPC Pleural Insertion Set
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