Orthospec

GUDID 07290016498417

Orthospec is based on shock wave therapy method and is intended to apply shock waves to the heel tissue of patients who have Proximal Plantar Fasciiti

MEDISPEC LTD.

Spark-gap orthopaedic extracorporeal shock wave therapy system

• Primary Device ID: 07290016498417
• NIH Device Record Key: 1ff08c82-3657-4495-9775-aa509907937e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthospec
• Version Model Number: OR-3-A999u
• 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	07290016498417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040026

FDA Product Code

• NBN: Generator, Shock-Wave, For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-22

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
• 07290016498301 - Econolith E3000: 2018-09-10
• 07290016498318 - Econolith E3000: 2018-09-10
• 07290016498356 - Econolith EM1000: 2018-09-10