Home GUDID 00812212030337 TracStar LDP Large Distal Platform
Primary DI 00812212030337
Brand TracStar LDP Large Distal Platform
Company IMPERATIVE CARE, INC.
Model ICAC088095
Catalog number ICAC088095
Device description TracStar LDP, 95 cm
Published 2021-09-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DQY Catheter, Percutaneous NRY Catheter, Thrombus Retriever QJP Catheter, Percutaneous, Neurovasculature
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQY Catheter, Percutaneous Cardiovascular 2 NRY Catheter, Thrombus Retriever Cardiovascular 2 QJP Catheter, Percutaneous, Neurovasculature Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812212030337 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 00812212030337 00812212030337 812212030337 0812212030337
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Length 0 Lumen/Inner Diameter 0 Outer Diameter 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Special Storage Condition, Specify 0 0 Store in a cool, dry place at room temperature.
Regulatory Flags# DUNS number 080816678 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00812212030764 Zoom 4S Catheter ICRC04S160 ICRC04S160 2025-11-24 00812212030771 Zoom 4S Catheter ICRC04S144 ICRC04S144 2025-11-24 00812212030788 Zoom 4S Catheter ICRC04S125 ICRC04S125 2025-11-24 00812212030108 TracStar™ Large Distal Platform ICAC088080 ICAC088080 2019-04-30 00812212030115 TracStar™ Large Distal Platform ICAC088090 ICAC088090 2019-04-30 00812212030146 ZOOM™ 88 Large Distal Platform ICFC088100 ICFC088100 2019-04-30 00812212030153 ZOOM™ 88 Large Distal Platform ICFC088110 ICFC088110 2019-04-30 00812212030573 Zoom 88 Large Distal Platform Support ICTC088100S ICTC088100S 2023-06-02 00812212030511 Zoom RDL Radial Access System, 95cm ICTC088095R ICTC088095R 2022-09-28 00812212030528 Zoom RDL Radial Access System, 105cm ICTC088105R ICTC088105R 2022-09-28 00812212030535 Zoom RDL Radial Access System, 110cm ICTC088110R ICTC088110R 2022-09-28 00812212030566 Zoom RDL Radial Access System, 103cm ICTC088103R ICTC088103R 2022-09-28 00812212030399 TracStar™ Large Distal Platform ICAC088095 ICAC088095 2022-08-11 00812212030405 ZOOM™ 88 Large Distal Platform ICTC088110 ICTC088110 2022-08-11 00812212030467 TracStar™ Large Distal Platform ICAC088105 ICAC088105 2022-08-11 00812212030344 TracStar LDP Large Distal Platform ICAC088105 ICAC088105 2021-09-22 00812212030351 ZOOM™ 88 Large Distal Platform ICTC088100 ICTC088100 2021-09-22 00812212030368 Zoom 88 Large Distal Platform ICTC088110 ICTC088110 2021-09-22 00812212030504 ZOOM™ 88-T Large Distal Platform ICTC088110 ICTC088110 2021-09-22 00812212030160 ZOOM™ 88-T Large Distal Platform ICTC088100 ICTC088100 2020-03-06
Other Devices Sharing Product Codes# 
imperativecare.com