Rocket

Basic Information

• Brand Name: Rocket
• Primary DI: 05055270914224
• Version / Model: R57596
• Catalog Number: R57596
• Company Name: ROCKET MEDICAL PLC
• Labeler DUNS: 544313588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 699ac2e6-02a5-4198-8064-2494e3c2f594

Device Description

Rocket Microsyringe for Embryo Transfer

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: 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
40717	X-ray contrast medium, inhaled gas	A gas formulation that is intended to be inhaled by the patient in order to temporarily enable or enhance the ability to differentially visualize targeted body structures on images generated by various diagnostic x-ray systems, e.g., computed tomography (CT) or fluoroscopy. It is used in x-ray imaging applications and intended to increase the ability to differentiate between normal and pathological conditions when analysing or interpreting medical images and information generated using a diagnostic x-ray system. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05055270935618	GS1		50	In Commercial Distribution
Primary	05055270914224	GS1
Package	05055270957016	GS1		2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K994327	000

Device Sizes

Type	Value	Unit	Text
Total Volume	0.3	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 101 – 101 KiloPascal
• 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