Econolith E3000

GUDID 07290016498301

MEDISPEC LTD.

Electrohydraulic lithotripsy system

• Primary Device ID: 07290016498301
• NIH Device Record Key: c33be345-8799-4f81-934b-89f005a14e85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Econolith E3000
• Version Model Number: SW-6-A999b
• Company DUNS: 600300909
• Company Name: MEDISPEC LTD.
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016498301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040461

FDA Product Code

• LNS: Lithotriptor, Extracorporeal Shock-Wave,Urological

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: 2018-09-10
• Device Publish Date: 2018-08-08

On-Brand Devices [Econolith E3000]

• 07290016498318: SW-6-A999d
• 07290016498301: SW-6-A999b