Omnispec ED1000

GUDID 07290016498110

Shock wave therapy

MEDISPEC LTD.

Hand-held electric massager

• Primary Device ID: 07290016498110
• NIH Device Record Key: d573f1a9-b8fa-46ce-a966-756643a5fbad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnispec ED1000
• Version Model Number: OR-5-A999k
• Company DUNS: 600300909
• Company Name: MEDISPEC LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016498110 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

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: 2023-06-15
• Device Publish Date: 2023-06-07

Devices Manufactured by MEDISPEC LTD.

• 07290016498455 - Lithospec: 2023-06-16 Intracorporeal Lithoripter
• 07290016498110 - Omnispec ED1000: 2023-06-15Shock wave therapy
• 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
• 07290016498301 - Econolith E3000: 2018-09-10
• 07290016498318 - Econolith E3000: 2018-09-10
• 07290016498356 - Econolith EM1000: 2018-09-10