SHOCKPULSE

GUDID 00821925043763

LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE 11.3 Fr (3.76 mm) x 396 mm (3/Pk)

Gyrus Acmi, Inc.

Ultrasonic lithotripsy system probe, single-use

• Primary Device ID: 00821925043763
• NIH Device Record Key: b6d76867-5d82-421e-9091-807a17474612
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHOCKPULSE
• Version Model Number: SPL-PDBX376
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925043763 [Package]; Contains: 00821925044241; Package: [3 Units]; In Commercial Distribution
GS1	00821925044241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142428

FDA Product Code

• FEO: Lithotriptor, Ultrasonic

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: 2024-08-01
• Device Publish Date: 2024-07-24

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