SHOCKPULSE

Basic Information

• Brand Name: SHOCKPULSE
• Primary DI: 00821925044180
• Version / Model: SPL-PDBX097
• Company Name: Gyrus ACMI, LLC
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-24
• Public Version: 3
• Public Version Date: 2024-12-12
• Public Version Status: Update
• Public Device Record Key: 8e6e1070-c035-4a33-9b23-f151de0e7213

Device Description

LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE, 2.9 Fr (0.97 mm) x 578 mm (3/PK)

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	876.4480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60703	Ultrasonic lithotripsy system probe, single-use	A slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00821925043725	GS1		3	In Commercial Distribution
Primary	00821925044180	GS1

Premarket Submissions

Submission Number	Supplement Number
K171024	000