ShockPulse

GUDID 00821925043633

CYBERWAND RENA BLADDER PROBE

Gyrus Acmi, Inc.

Ultrasonic lithotripsy system handpiece Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system

• Primary Device ID: 00821925043633
• NIH Device Record Key: 05c1cd15-f6a4-414a-8d22-ca25ef98bf18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShockPulse
• Version Model Number: CW-USLRBP
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925043633 [Primary]

FDA Product Code

• FFK: Lithotriptor, electro-hydraulic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-11
• Device Publish Date: 2020-03-03

On-Brand Devices [ShockPulse]

• 00821925044197: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• 00821925043831: SHOCKPULSE LITHOTRIPSY TRANSDUCER
• 00821925044203: SHOCKPULSE LITHOTRIPSY GENERATOR
• 00821925043718: SHOCKPULSE LITHOTRIPSY POWER CORD
• 00821925043701: SHOCKPULSE LITHOTRIPSY NOSE CONE
• 00821925043695: SHOCKPULSE LITHOTRIPSY FOOTSWITCH
• 00821925043688: SHOCKPULSE LITHOTRIPSY CLEANING STYLET (SMALL)
• 00821925043671: SHOCKPULSE LITHOTRIPSY CLEANING STYLET (LARGE)
• 00821925043633: CYBERWAND RENA BLADDER PROBE