StoneBreaker

Basic Information

• Brand Name: StoneBreaker
• Primary DI: 00827002526044
• Version / Model: G52604
• Catalog Number: SBL-KIT1
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8e4976e5-ef6b-4180-b60e-db22d3ca9cec
• Distribution End Date: 2018-03-08

Device Description

StoneBreaker Pneumatic Lithotripter

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFK	Lithotriptor, electro-hydraulic	Gastroenterology, Urology	876.4480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47049	Hand pneumatic lithotripsy system, urinary	An assembly of devices, held by the operator, that uses pneumatically-created ballistic shock waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidneys, ureters, and bladder) for their removal. It typically includes a handpiece in which is placed a disposable carbon dioxide (CO2) cartridge as the source of energy, a probe that is attached to the handpiece to transmit energy directly to a calculus for high-speed fragmentation in situ, and an exhaust outlet for the attachment of a hose for the removal of the spent gases from the site of operation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002526044	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.