Rocket

Basic Information

• Brand Name: Rocket
• Primary DI: 05055270912169
• Version / Model: R50000
• Catalog Number: R50000
• Company Name: ROCKET MEDICAL PLC
• Labeler DUNS: 544313588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-17
• Public Version: 3
• Public Version Date: 2018-06-26
• Public Version Status: Update
• Public Device Record Key: 77a886b3-7853-42d7-b24b-7cb7e255e3ed

Device Description

Rocket Suture ScIssors 11cm

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: Labeling does not contain MRI Safety Information
• 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
13502	Suture scissors	A hand-held surgical instrument used during surgery to cut suture or ligature material, i.e., to divide lengths or remove excessive/unwanted ends. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically metallic and is available in various designs and sizes; the blades may have different shapes, e.g., they can be curved or straight with a hook-like tip to capture the suture/ligature as it is cut. It is not a dedicated ophthalmic device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05055270954954	GS1	Box	12	In Commercial Distribution
Package	05055270933553	GS1	Carton	25	In Commercial Distribution
Primary	05055270912169	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	11.0	Centimeter

Storage Conditions

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