Rocket

Basic Information

• Brand Name: Rocket
• Primary DI: 05055270913845
• Version / Model: R57493
• Catalog Number: R57493
• Company Name: ROCKET MEDICAL PLC
• Labeler DUNS: 544313588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ffe74f87-a1f2-4a78-9b0a-5a88c8be73fe

Device Description

Rocket Cervix Adaptor Small - 27mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
18746	Intrauterine imaging medium catheter	A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05055270935236	GS1	Carton	10	In Commercial Distribution
Primary	05055270913845	GS1
Package	05055270956637	GS1	Box	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	27.0	Millimeter

Storage Conditions

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