Econolith EM1000

GUDID 07290016498394

MEDISPEC LTD.

Electromechanical lithotripsy system, extracorporeal

• Primary Device ID: 07290016498394
• NIH Device Record Key: fdc2c16d-fdae-42cf-8789-50a2708aa15d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Econolith EM1000
• Version Model Number: SW-8-A999r
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016498394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063504

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 EM1000]

• 07290016498394: SW-8-A999r
• 07290016498387: SW-8-A999q
• 07290016498370: SW-8-A999m
• 07290016498363: SW-8-A999d
• 07290016498356: SW-8A999b