Rocket R57430-CONE

GUDID 05055270981387

Hysterocone - 6Fg HSG and HyCoSy Catheter

ROCKET MEDICAL PLC

Intrauterine imaging medium catheter

• Primary Device ID: 05055270981387
• NIH Device Record Key: f98fc703-9438-4a94-80dd-2c450b772f88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rocket
• Version Model Number: R57430-CONE
• Catalog Number: R57430-CONE
• Company DUNS: 544313588
• Company Name: ROCKET MEDICAL PLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	05055270981370 [Primary]
GS1	05055270981387 [Package]; Contains: 05055270981370; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	05055270981394 [Package]; Package: Outer Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000340

FDA Product Code

• HES: Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

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

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