2 French Electrohydraulic Lithotriptor Probe

GUDID 00821925001732

Gyrus Acmi, Inc.

Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece Pneumatic lithotripsy system handpiece

• Primary Device ID: 00821925001732
• NIH Device Record Key: c6827705-5630-4a1c-9743-a5e97735ecb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2 French Electrohydraulic Lithotriptor Probe
• Version Model Number: E4-2F
• 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	00821925001732 [Package]; Contains: 00821925040229; Package: [3 Units]; In Commercial Distribution
GS1	00821925040229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011848

FDA Product Code

• FFK: Lithotriptor, electro-hydraulic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-05

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• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)