Medical Device Manufacturer definition

Medical Device Manufacturer means a manufacturer of diagnostic and laboratory products, orthopedic products, surgical devices, cardiac rhythmia management products, and implantable cardiac defibrillators.
Sample 1

Examples of Medical Device Manufacturer in a sentence

  • The Company is a Medical Device Manufacturer, and in the business of providing medical products and services on a Global basis.

  • The Company is a Medical Device Manufacturer, and in the business of providing medical products and services on a global basis.

  • The Company is a Medical Device Manufacturer, and in the business of providing medical and consumer products and services on a Global basis.

  • Contractor hereby represents to Buyer that it shall, at its sole cost and expense, timely register with the FDA as a Contract Medical Device Manufacturer, or cause to be timely registered with the FDA, in accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 as amended.

  • Bulova agrees to become registered with the FDA as a Contract Medical Device Manufacturer, in accordance with FDA Cosmetic Act 21 CFR Part 807 as amended, and manufacture all products in compliance with all applicable regulations.

  • Contractor hereby represents to Buyer that it shall, at its sole cost and expense, timely register with the FDA as a Contract Medical Device Manufacturer, or cause to be timely registered with the FDA, in accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 as amended, each establishment which Contractor or a subcontractor of Contractor intends to use to manufacture, and/or make repairs to, any Product.

  • McAleer, Vice-President/General Manager Plant 105 FIRM NAME Integra LifeSciences Corporation STREET ADDRESS 105 Morgan Ln CITY, STATE, ZIP CODE, COUNTRY Plainsboro, NJ 08536-3339 TYPE ESTABLISHMENT INSPECTED Medical Device Manufacturer This document lists observations made by the FDA representative(s) during the inspection of your facility.

  • Ohio Medical Corporation Medical Device Manufacturer Common Stock (8,512 shares) (a, d) $ 15,763,637 $ — Series A Convertible Preferred Stock 16.0000% PIK (31,346 shares) (a, b) 30,000,000 6,050,797 Series C Convertible Preferred Stock 16.0000% PIK (9,927shares) (a, b) 22,618,466 32,479,292 68,382,103 38,530,089 U.S. Gas & Electric, Inc.

Related to Medical Device Manufacturer

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Third Party Manufacturer means (i) a Third Party whose primary business is contract manufacturing, or (ii) a Third Party who has a contractual arrangement with Licensee or with a sublicensee of Licensee that includes manufacturing of Client Product and/or Drug Product by such Third Party for Licensee or such sublicensee.

  • Manufacturer means the person or body responsible to the approval authority for all aspects of the type approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stages of the construction of the vehicle which is the subject of the approval process.

  • Original manufacturer means the original component manufacturer, the original equipment manufacturer, or the contract manufacturer.

  • Satellite Manufacturer means, with respect to any Satellite, the prime contractor and manufacturer of such Satellite.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • API means American Petroleum Institute.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Engine Manufacturer means CFM International, Inc.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.