D FDA C106039 FDA CDRH GUDID Terminology C124108 Catheter Gauge A measure of the outer diameter of a catheter. The French (F or Fr) gauge system is commonly used to measure the size of a catheter. The measure of the outer diameter of a catheter. A FDA C106039 FDA CDRH GUDID Terminology C150142 Shaft length The length of the balloon catheter tube that extends from the catheter handle to the distal end of the catheter. The length of the balloon catheter tube that extends from the catheter handle to the distal end of the catheter. A FDA C106039 FDA CDRH GUDID Terminology C150144 Introducer Sheath Compatibility Introducer Size|Sheath Compatibility|Sheath Size The size of the device that would fit through an introducer sheath. The size of the device that would fit through an introducer sheath. A FDA C106039 FDA CDRH GUDID Terminology C150145 Balloon Diameter Nominal Diameter The nominal diameter of the balloon per manufacturer specification. The nominal diameter of the balloon per manufacturer specification. A FDA C106039 FDA CDRH GUDID Terminology C150146 Balloon Length Nominal Diameter The nominal length of the balloon per manufacturer specification. The nominal length of the balloon per manufacturer specification. A FDA C106039 FDA CDRH GUDID Terminology C150147 Nominal (Inflation) Pressure Balloon pressure at balloon nominal diameter condition. Balloon pressure at balloon nominal diameter condition. A FDA C106039 FDA CDRH GUDID Terminology C150161 Outer Diameter (OD) Crossing Profile|Distal Outer Diameter (OD)|Proximal Outer Diameter (OD) The nominal measure of the outer diameter of the the balloon. The nominal measure of the outer diameter of the the balloon. A FDA C106039 FDA CDRH GUDID Terminology C150163 Balloon Catheter Tip Length The length of the distal end of the catheter to the distal end of the balloon. The length of the distal end of the catheter to the distal end of the balloon. A FDA C106039 FDA CDRH GUDID Terminology C150164 Rated Burst Pressure RBP Calculated pressure at which a balloon would not be expected to burst. Based on an appropriate confidence and reliability from measured burst pressures. (ISO 25539-2) Calculated pressure at which a balloon would not be expected to burst. Based on an appropriate confidence and reliability from measured burst pressures. A FDA C106039 FDA CDRH GUDID Terminology C150184 Catheter Length The length of the catheter. The length of the catheter. A FDA C106039 FDA CDRH GUDID Terminology C150185 Guidewire Compatibility Inner Lumen Dimension|Maximum Guidewire Size The size of the guidewires that will fit through the inner lumen of the device. The size of the guidewires that will fit through the inner lumen of the device. A FDA C106039 FDA CDRH GUDID Terminology C150186 Catheter Working Length Effective Length|Working Length The length of the catheter that can be inserted into the body or the working/functional measurement from the beginning to the end of delivery system. The length of the catheter that can be inserted into the body or the working/functional measurement from the beginning to the end of delivery system. A FDA C106039 FDA CDRH GUDID Terminology C150187 Tip Bend Radius The radius of an imaginary circle drawn inside of a curve of a curved catheter or guidewire. The radius of an imaginary circle drawn inside of a curve of a curved catheter or guidewire. A FDA C106039 FDA CDRH GUDID Terminology C150189 Nominal Stent Diameter Stent Diameter Deployed stent diameter, as marked on packaging. Deployed stent diameter, as marked on packaging. A FDA C106039 FDA CDRH GUDID Terminology C150190 Nominal Stent Length Stent Length Deployed stent length, as marked on the packaging. Deployed stent length, as marked on the packaging. A FDA C106039 FDA CDRH GUDID Terminology C150192 Tapered Stent Smaller Diameter Distal Stent|Tapered Stent Smallest Diameter The diameter of the portion of the tapered end of the stent that is the smaller of the two tapered ends. The diameter of the portion of the tapered end of the stent that is the smaller of the two tapered ends. A FDA C106039 FDA CDRH GUDID Terminology C150194 Tapered Stent Larger Diameter The diameter of the portion of the tapered end of the stent that is the larger of the two tapered ends. The diameter of the portion of the tapered end of the stent that is the larger of the two tapered ends. A FDA C106039 FDA CDRH GUDID Terminology C150196 Tapered Stent Length The length of the tapered portion of the stent. The length of the tapered portion of the stent. A FDA C106039 FDA CDRH GUDID Terminology C150197 Maximum Stent Diameter Maximum diameter to which a stent can be distended. Maximum diameter to which a stent can be distended. A FDA C106039 FDA CDRH GUDID Terminology C150200 Atherectomy Device Tip Length The length of the tip of the atherectomy device, if present. The length of the tip of the atherectomy device, if present. A FDA C106039 FDA CDRH GUDID Terminology C150226 Inner Diameter The measurement of the diameter of the inner catheter tubing which goes over the guidewire. The measurement of the diameter of the inner catheter tubing which goes over the guidewire. A FDA C106039 FDA CDRH GUDID Terminology C150229 Crossing Profile Catheter Gauge|Catheter Size The maximum diameter of the entire device entering the patient. ASTM F2081 definition: A linear measure of the maximum breadth of the stent/delivery system over the distal most region of the delivery system. A linear measure of the maximum breadth of the stent/delivery system over the distal most region of the delivery system. A FDA C106039 FDA CDRH GUDID Terminology C150230 Cutter Length The length of the cutter component for atherectomy devices that are used to cut plaque/thrombus. The length of the cutter component for atherectomy devices that are used to cut plaque/thrombus. A FDA C106039 FDA CDRH GUDID Terminology C150233 Cutter Diameter The diameter of the cutter component for atherectomy devices that is used to cut the plaque/thrombus. The diameter of the cutter component for atherectomy devices that is used to cut the plaque/thrombus. A FDA C106039 FDA CDRH GUDID Terminology C150243 Rotating Component Length The length of the rotating component of an atherectomy device. The length of the rotating component of an atherectomy device. A FDA C106039 FDA CDRH GUDID Terminology C150244 Rotating Component Diameter The diameter of the rotating component of an atherectomy device. The diameter of the rotating component of an atherectomy device. A FDA C106039 FDA CDRH GUDID Terminology C150371 Guidewire Length The length of the guidewire. The length of the guidewire. A FDA C106039 FDA CDRH GUDID Terminology C150372 Guidewire Diameter The diameter of the guidewire. The diameter of the guidewire. C FDA C106039 FDA CDRH GUDID Terminology C101716 Global Unique Device Identification Database Submission GUDID The submission of a DI Record through SPL XML Message as a type of SPL Document. The submission of a global unique device identification record. C FDA C106039 FDA CDRH GUDID Terminology C101697 Peracetic Acid A sterilization process that uses the vaporized form of a chemical (peracetic acid) to kill microorganisms. A sterilization process that uses the vaporized form of peracetic acid to kill microorganisms. C FDA C106039 FDA CDRH GUDID Terminology C101674 Human Cell, Tissue, or Cellular or Tissue-based Product HCT/P Human cell, tissue, or cellular or tissue-based product (HCT/P) contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3. A product that contains human cells or tissue.