Rocket

Basic Information

• Brand Name: Rocket
• Primary DI: 05055270965752
• Version / Model: R51400-MI-PL
• Catalog Number: R51400-MI-PL
• Company Name: ROCKET MEDICAL PLC
• Labeler DUNS: 544313588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7807254c-5843-4d41-aa21-e60872a03f7b

Device Description

Rocket IPC Pleural MINI Insert Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• 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
11266	Fixed-diameter cervical dilator, reusable	A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05055270965776	GS1		1	In Commercial Distribution
Primary	05055270965752	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123033	000

Storage Conditions

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