Econolith E2000

GUDID 07290016498257

MEDISPEC LTD.

Electrohydraulic lithotripsy system

• Primary Device ID: 07290016498257
• NIH Device Record Key: bd318767-35b2-4198-9177-2a1b912549de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Econolith E2000
• Version Model Number: SW-7-A999
• 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	07290016498257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950043

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

Devices Manufactured by MEDISPEC LTD.

• 07290016498455 - Lithospec: 2023-06-16 Intracorporeal Lithoripter
• 07290016498110 - Omnispec ED1000: 2023-06-15 Shock wave therapy
• 07290016498615 - Slimspec: 2023-06-15 Radial wave therapy
• 07290016498752 - Radialspec: 2023-06-15 Radial wave therapy
• 07290016498257 - Econolith E2000: 2018-09-10
• 07290016498257 - Econolith E2000: 2018-09-10
• 07290016498301 - Econolith E3000: 2018-09-10
• 07290016498318 - Econolith E3000: 2018-09-10
• 07290016498356 - Econolith EM1000: 2018-09-10