Home GUDID 00885403530558 Fogarty
Primary DI 00885403530558
Brand Fogarty
Company Becton, Dickinson And Company
Model 12TLW804F
Catalog number 12TLW804F
Device description Fogarty Thru-lumen Embolectomy Catheter
Published 2026-08-14
Public version status New
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 DXE Catheter, embolectomy KRA Catheter, continuous flush
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXE Catheter, Embolectomy Cardiovascular 2 KRA Catheter, Continuous Flush Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00690103043518 Previous GS1 0 00885403530558 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 00690103043518 00690103043518 690103043518 0690103043518 00885403530558 00885403530558 885403530558 0885403530558
GMDN Terms# Term, Definition table Term Definition Thrombectomy balloon catheter A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Length 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Special Storage Conditions (see IFU) Special Storage Condition, Specify 0 0 Store in a cool, dry place.
Regulatory Flags# DUNS number 145014099 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex true No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00885403542667 TRUWAVE Becton, Dickinson And Company KRA 2026-09-05 00885403530374 Fogarty Corkscrew Becton, Dickinson And Company DXE 2026-09-04 00885403530381 Fogarty Corkscrew Becton, Dickinson And Company DXE 2026-09-04 00885403530398 Fogarty Corkscrew Becton, Dickinson And Company DXE 2026-09-04 00884450466995 Needle's Eye Snare® Merit Medical Systems, Inc. DXE 2026-08-27 00884450466988 Needle's Eye Snare® Merit Medical Systems, Inc. DXE 2026-08-25 00884450467008 Needle's Eye Snare® Merit Medical Systems, Inc. DXE 2026-08-25 00885403530534 Fogarty Becton, Dickinson And Company KRA 2026-08-14 00885403530534 Fogarty Becton, Dickinson And Company DXE 2026-08-14 00885403530541 Fogarty Becton, Dickinson And Company DXE 2026-08-14 00885403530541 Fogarty Becton, Dickinson And Company KRA 2026-08-14 00885403530572 Fogarty Becton, Dickinson And Company DXE 2026-08-14 00885403530572 Fogarty Becton, Dickinson And Company KRA 2026-08-14 00885403530589 FOGARTY Becton, Dickinson And Company DXE 2026-08-14 00885403530589 FOGARTY Becton, Dickinson And Company KRA 2026-08-14 00885403523581 VAMP Becton, Dickinson And Company KRA 2026-07-31 00885403523598 VAMP Becton, Dickinson And Company KRA 2026-07-31 00885403523734 VAMP Becton, Dickinson And Company KRA 2026-07-31 00885403530404 Fogarty Becton, Dickinson And Company DXE 2026-07-31 00885403530411 Fogarty Becton, Dickinson And Company DXE 2026-07-31 00885403530428 Fogarty Becton, Dickinson And Company DXE 2026-07-31 00885403530442 Fogarty Becton, Dickinson And Company DXE 2026-07-31 00885403530466 Fogarty Becton, Dickinson And Company DXE 2026-07-31 00885403530565 Fogarty Becton, Dickinson And Company KRA 2026-07-31 00850013694099 MicroGuide Micro Medical Solutions, Inc. KRA 2026-04-24 00810123710522 Triever20 Curve Inari Medical, Inc. KRA 2023-12-15 00812339030319 Pounce Venous Thrombectomy System Surmodics, Inc. KRA 2023-10-27 00850291007277 ClotTriever XL Catheter Inari Medical, Inc. KRA 2023-05-09 00850291007376 Artix™ AX Inari Medical, Inc. KRA 2023-04-24 00812339030302 Pounce™ Venous Thrombectomy System Surmodics, Inc. KRA 2022-06-22