ShockPulse

GUDID 00821925044203

SHOCKPULSE LITHOTRIPSY GENERATOR

Gyrus Acmi, Inc.

Pneumatic/ultrasonic lithotripsy system

• Primary Device ID: 00821925044203
• NIH Device Record Key: 034f3ebe-e4ff-4afb-9d9c-50b3c7392a2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShockPulse
• Version Model Number: SPL-G
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00821925044203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171024

FDA Product Code

• FEO: Lithotriptor, ultrasonic

Sterilization

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

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
• 00821925043763: LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE 11.3 Fr (3.76 mm) x 396 mm (3/Pk)
• 00821925043756: LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE 10.2 Fr (3.40 mm) x 396 mm (3/Pk)
• 00821925043749: LITHOTRIPSY PROBE, LITHOTRIPSY PROBE STERILE SINGLE USE, ShockPulse-SE 5.5 Fr (1.83 mm) x 418 mm
• 00821925043732: LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE, 4.5 Fr (1.50 mm) x 564 mm (3/Pk)
• 00821925043725: LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE, 2.9 Fr (0.97 mm) x 578 mm (3/Pk)
• 00821925043824: LITHOTRIPSY SYSTEM SHOCKPULSE-SE
• 00821925043800: LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 10.2 Fr (3.40 mm) x 396 mm
• 00821925043794: LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 5.5 Fr (1.83 mm) x 418 mm
• 00821925043787: LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 4.5 Fr (1.50 mm) x 564 mm