Indicates that the device is intended for one use or on a single patient during a single procedure. At least one of the products in the combination product must be a device in this case. Indicates that the product is comprised of two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity packaged together as a single package or packaged separately for the intended use together as defined under 21 CFR 3.2(e). Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and is being distributed as a medical device. Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under.
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) The device is exempt from Direct Marking requirements under 21 CFR 801.45.įDA Premarket submission is not required for this device. Number of medical devices in the base package.ĭevice Subject to Direct Marking (DM), but Exempt Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b). Indicates the date this particular package configuration is discontinued by the labeler. The number of packages with the same Primary DI or Package DI within a given packaging configuration. Organization accredited by FDA to operate a system for the issuance of UDIs. Indicates whether the device is in commercial distribution as defined under 21 CFR 807.3(b). The device may or may not still be available for purchase in the marketplace. Indicates the date the device is no longer held or offered for sale by the labeler on record. Indicates the date the DI Record is published and available via Public Search. The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product.Īdditional relevant information about the device that is not already captured as a distinct GUDID data attribute. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. The version or model found on the device label or accompanying packaging used to identify a category or design of a device. The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol.
This information may 1) be on a label attached to a durable device, 2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. Company name associated with the labeler DUNS Number entered in the DI Record.
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