C FDA C106039 FDA CDRH GUDID Terminology C101669 Manufacturing Date Production Identifier The date on which a device was manufactured. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. The production identifier is the date of manufacture. C FDA C106039 FDA CDRH GUDID Terminology C101670 Expiration Date Production Identifier The date by which the label of a device states the device must or should be used. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. The production identifier is the expiration date. C FDA C106039 FDA CDRH GUDID Terminology C101671 Serial Number Production Identifier The number assigned to individually identify a single unit or device. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. The production identifier is the serial number. C FDA C106039 FDA CDRH GUDID Terminology C101672 Lot or Batch Number Production Identifier The number assigned to one or more device(s) that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. The production identifier is the lot or batch number. C FDA C106039 FDA CDRH GUDID Terminology C101679 Exempt from Direct Marking (DM) The device meets the requirements stipulated under 21 CFR, but is exempt from Direct Marketing. An indication that a device is exempt from direct marking requirements. C FDA C106039 FDA CDRH GUDID Terminology C101685 Inner/Lumen Diameter The length of a straight line passing through the center of the inner open space or cavity of a circular or spheroid object (such as a tubular organ) that connects two points on the circumference. The length of a straight line passing through the center of the inner open space of a circular or spheroid object that connects two points on the circumference. C FDA C106039 FDA CDRH GUDID Terminology C101708 Customer Contact A public-facing customer contact for the Labeler company responsible to support the reported device. Customer contact information for a device labeler. C FDA C106039 FDA CDRH GUDID Terminology C106038 Not Made with Natural Rubber Latex Natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information. Only applicable to devices not subject to the requirements under 21 CFR 801.437. Not all medical products that are NOT made with natural rubber latex will be marked. The composition of the materials of an item do not contain natural rubber latex. C FDA C106039 FDA CDRH GUDID Terminology C106044 MRI Safety Labeling Information This data element identifies what, if any, information on MRI Safety is presented by the labeler in the device labeling. Safety information about the MRI device that is included on the device label. C FDA C106039 FDA CDRH GUDID Terminology C113843 Donation Identification Number Production Identifier The number assigned to a device containing human cellular or tissue components (HCT/P) which relates the HCT/P product to the donor and all records pertaining to the HCT/P product. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. A number assigned to a device that contains human cells or tissue. The number can be found on the device label or packaging. D FDA C106039 FDA CDRH GUDID Terminology C101702 Second Greatest Diameter The second greatest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the circumference. The second longest possible length of a straight line passing through the center of a nearly circular or spheroid object that connects two points on the circumference. D FDA C106039 FDA CDRH GUDID Terminology C101709 Third Greatest Diameter The third greatest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the circumference. The third longest possible length of a straight line passing through the center of a nearly circular or spheroid object that connects two points on the circumference. D FDA C106039 FDA CDRH GUDID Terminology C96684 Greatest Diameter The greatest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the circumference. The longest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the circumference. A FDA C106039 FDA CDRH GUDID Terminology C112332 Pore Size A quantitative or qualitative measurement of the physical dimensions of the pores in a material. A FDA C106039 FDA CDRH GUDID Terminology C124108 Catheter Gauge The measure of the outer diameter of a catheter. A FDA C106039 FDA CDRH GUDID Terminology C124136 Outer/Greatest Diameter The greatest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the circumference. The longest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the outer circumference. A FDA C106039 FDA CDRH GUDID Terminology C25195 Pressure The force applied to a unit area of surface. The force applied to a unit area of surface. A FDA C106039 FDA CDRH GUDID Terminology C25208 Weight The vertical force exerted by a mass as a result of gravity. The vertical force exerted by a mass as a result of gravity. A FDA C106039 FDA CDRH GUDID Terminology C25244 Area The extent of a 2-dimensional surface enclosed within a boundary. The extent of a 2-dimensional surface enclosed within a boundary. A FDA C106039 FDA CDRH GUDID Terminology C48161 Force The influence that produces a change in a physical quantity; physical energy or intensity. A FDA C106039 FDA CDRH GUDID Terminology C63850 Particle An object with finite mass and size parameters. A FDA C106039 FDA CDRH GUDID Terminology C67505 Angle The inclination of one line to another or the plane of one object to another. The inclination of one line to another or the plane of one object to another.