Finished Device definition

Finished Device means any Product that constitutes a device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized.
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Finished Device means a device, or any accessory to a device, that is suitable for use, without regard to whether it is packaged or labelled for commercial distribution.
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Finished Device shall have that same meaning set forth in 21CFR§820.3.
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Examples of Finished Device in a sentence

  • All controlled documentation, including that which is Supplier-generated, required for the manufacture and testing of the SynCardia Finished Device will be maintained by SynCardia in the Device Master Record (DMR).

  • SynCardia shall be responsible for all recall activities related to Finished Device and for reporting to regulatory authorities according to SynCardia’s written procedures.

  • In addition, each of the Parties shall notify the other promptly if any batch or lot of the Product or Finished Device is the subject of a recall, market withdrawal or correction, and the Parties shall cooperate in the handling and disposition of such recalled, withdrawn or corrected Product or Finished Devices.

  • The Parties shall cooperate in the investigation of any customer complaint related to the use of the Product or Finished Device.

  • Except as specified or approved in writing in advance by Buyer, Seller will not knowingly incorporate into the Finished Device or Product any Intellectual Property that is owned by third parties.

  • Buyer acknowledges that Seller has not made and is not obligated to make any independent inquiry or investigation as to whether the Product, Finished Device or Manufacturing Activities infringe upon any patent, copyright or trade secret.

  • Seller will supply documentation as requested by Buyer to support a regulatory filing for the Product and/or Finished Device or any changes to any filings.

  • Upon request of Buyer, Seller shall reasonably support any regulatory activities (including pre-Approval inspection) of Buyer necessary for regulatory approval of the Product and/or Finished Device.

  • Concurrent with the Quarterly update of the Forecast, Buyer shall issue Purchase Order(s) for new binding obligations not covered by previous Purchase Orders, which Purchase Orders shall include: the Product or Finished Device, quantity, Specifications, Delivery Date (which shall be in accordance with the applicable Lead Time), Delivery Location and Price.

  • Cost estimates for Product and/or Finished Device is shown in either the applicable Statement of Work or Exhibit C.


More Definitions of Finished Device

Finished Device under 21 CFR 820.3(l) means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
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Finished Device. “Delivered Device” means a Device that has been produced at CCC and: (i) has been shipped to a destination indicated by EndoStim; or (ii) has entered into CCC’s stock of finished products and is ready to ship; or (iii) has been held at any other production stage upon EndoStim request.
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