Home GUDID 00811311020928 ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter
Primary DI 00811311020928
Brand ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter
Company Silk Road Medical, Inc.
Model SR-4025-BC
Catalog number SR-4025-BC
Device description 4mm x 25mm
Published 2022-10-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LIT Catheter, Angioplasty, Peripheral, Transluminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00811311020928 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00811311020928 00811311020928 811311020928 0811311020928
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Regulatory Flags# DUNS number 022516829 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00811311021260 ENROUTE Transcarotid Stent FG11815 SR-080630-TCS 2023-06-22 00811311021277 ENROUTE Transcarotid Stent FG11815 SR-080640-TCS 2023-06-22 00811311021284 ENROUTE Transcarotid Stent FG11815 SR-090730-TCS 2023-06-22 00811311021291 ENROUTE Transcarotid Stent FG11815 SR-090740-TCS 2023-06-22 00811311021307 ENROUTE Transcarotid Stent FG11815 SR-100830-TCS 2023-06-22 00811311021314 ENROUTE Transcarotid Stent FG11815 SR-100840-TCS 2023-06-22 00811311021321 ENROUTE Transcarotid Stent FG11815 SR-100740-TCS 2023-06-22 00811311020362 ENROUTE Transcarotid Stent SR-0520-CS SR-0520-CS 2016-07-28 00811311020379 ENROUTE Transcarotid Stent SR-0530-CS SR-0530-CS 2016-07-28 00811311020386 ENROUTE Transcarotid Stent SR-0540-CS SR-0540-CS 2016-07-28 00811311020393 ENROUTE Transcarotid Stent SR-0620-CS SR-0620-CS 2016-07-28 00811311020409 ENROUTE Transcarotid Stent SR-0630-CS SR-0630-CS 2016-07-28 00811311020416 ENROUTE Transcarotid Stent SR-0640-CS SR-0640-CS 2016-07-28 00811311020423 ENROUTE Transcarotid Stent SR-0720-CS SR-0720-CS 2016-07-28 00811311020430 ENROUTE Transcarotid Stent SR-0730-CS SR-0730-CS 2016-07-28 00811311020447 ENROUTE Transcarotid Stent SR-0740-CS SR-0740-CS 2016-07-28 00811311020454 ENROUTE Transcarotid Stent SR-0820-CS SR-0820-CS 2016-07-28 00811311020461 ENROUTE Transcarotid Stent SR-0830-CS SR-0830-CS 2016-07-28 00811311020478 ENROUTE Transcarotid Stent SR-0840-CS SR-0840-CS 2016-07-28 00811311020485 ENROUTE Transcarotid Stent SR-0920-CS SR-0920-CS 2016-07-28
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