Rocket R57422-00-ST

GUDID 05055270935113

Rocket 5Fg HSG Sonohystogram Catheter

ROCKET MEDICAL PLC

Intrauterine imaging medium catheter

• Primary Device ID: 05055270935113
• NIH Device Record Key: 162f94d4-a4ab-491d-b021-0db1fe72aa50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rocket
• Version Model Number: R57422-00-ST
• Catalog Number: R57422-00-ST
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Catheter Gauge: 5 French
• Length: 30 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055270913722 [Primary]
GS1	05055270935113 [Package]; Contains: 05055270913722; Package: [10 Units]; In Commercial Distribution
GS1	05055270956514 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000340

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: 2016-09-02

On-Brand Devices [Rocket]

• 05055270942784: Rocket LX 17G CVS Needle
• 05055270973528: Rocket 7Fg HSG Sonohystogram Catheter
• 05055270973504: Rocket 17G ZX Aspiration Needle
• 05055270973474: Rocket 24Fg Seldinger Chest Drainage Kit
• 05055270973443: Rocket IPC DRessing Pack & Bag
• 05055270973412: Rocket IPC Peritoneal Insertion Set
• 05055270973382: Rocket IPC Mini Dressing Pack & Bag
• 05055270972552: Rocket 17G ZX Aspiration Needle
• 05055270972521: Rocket IPC Peritoneal MINI Insertion Set
• 05055270972491: Rocket IPC Peritoneal Insertion Set
• 05055270972460: Rocket IPC DIscharge Pack
• 05055270972316: Rocket 6Fg Thoracentesis Drainage Kit
• 05055270972286: Rocket 8Fg Thoracentesis Drainage Kit
• 05055270971654: Rocket IPC Mini Dressing Pack & Bottle
• 05055270971593: Rocket DIsposable Needle Guide
• 05055270971258: Rocket DIsposable Needle Guide
• 05055270971234: Rocket IPC Dressing Pack
• 05055270970411: Rocket DIsposable Bellows Set
• 05055270968050: Rocket IPC Dressing Pack & Bag Set
• 05055270967565: Rocket Seldinger Wide Bore Connector
• 05055270967473: Rocket DIsposable Needle Guide
• 05055270967411: Rocket Dilator & Needle Set
• 05055270967244: Rocket Stylet 18cm ET Pro Handle
• 05055270967213: Rocket Stylet 23cm ET Pro Handle
• 05055270966674: Rocket Seldinger 0.35" Guide Wire
• 05055270966490: Rocket 26Fg Blunt DIssection Kit
• 05055270966438: Rocket 20Fg Seldinger Chest Drainage Kit
• 05055270966407: Rocket 28Fg Blunt DIssection Kit
• 05055270966377: Rocket 12Fg Seldinger Chest Drainage Kit
• 05055270966346: Rocket 12Fg Seldinger Chest Drainage Kit
• 05055270966315: Rocket 16Fg Seldinger Chest Drainage Kit
• 05055270966285: Rocket 18Fg Seldinger Chest Drainage Kit
• 05055270966254: Rocket 18Fg Seldinger Chest Drainage Kit
• 05055270966131: Rocket DIsposable Needle Guide
• 05055270966094: Rocket DIsposable Needle Guide
• 05055270966063: Rocket DIsposable Needle Guide
• 05055270966032: Rocket DIsposable Needle Guide
• 05055270965929: Rocket IPC DIscharge Pack
• 05055270965899: Rocket IPC Mini Dressing Pack & Bottle
• 05055270965868: Rocket IPC 600ml Drainage Bottle
• 05055270965837: Rocket IPC Dressing Pack & Bottle Set
• 05055270965806: Rocket IPC Insertion Set
• 05055270965776: Rocket IPC Pleural MINI Insert Set
• 05055270965745: Rocket IPC Pleural Insertion Set
• 05055270965325: Rocket ThoracentesIs Catheter 8Fg
• 05055270964656: Rocket Seldinger Catheter Fixation Set
• 05055270965257: Rocket BLUE Needle Drain Procedure Tray
• 05055270965226: Rocket 17G SX Aspiration Needle
• 05055270964717: Rocket Seldinger Fixation Set
• 05055270964625: Rocket DIsposable Needle Guide