Home GUDID M84963520
Freeman Pancreatic Flexi-Stent
Primary DI M84963520
Brand Freeman Pancreatic Flexi-Stent
Company HOBBS MEDICAL, INC.
Model 6352
Catalog number 6352
Device description A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device.
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name FGE Catheter, Biliary, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M84963520 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Polymeric pancreatic stent, non-bioabsorbable A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.
Regulatory Flags# DUNS number 076769355 Device count 1 Lot or batch true Manufacturing date on label 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 M84921890 CleanCapture Aspiration Catheter 2189 2189 2026-01-14 M84921891 CleanCapture Aspiration Catheter 2189 2189 2026-01-14 M84960050 Hobbs Biliary Amsterdam Stent Kit 6005 6005 2016-09-21 M84960060 Hobbs Biliary Amsterdam Stent Kit 6006 6006 2016-09-21 M84960090 Hobbs Biliary Amsterdam Stent Kit 6009 6009 2016-09-21 M84960110 Hobbs Biliary Amsterdam Stent Kit 6011 6011 2016-09-21 M84960120 Hobbs Biliary Amsterdam Stent Kit 6012 6012 2016-09-21 M84960130 Hobbs Biliary Amsterdam Stent Kit 6013 6013 2016-09-21 M84960140 Hobbs Biliary Amsterdam Stent Kit 6014 6014 2016-09-21 M84960150 Hobbs Biliary Amsterdam Stent Kit 6015 6015 2016-09-21 M84963100 Freeman Pancreatic Flexi-Stent Kit 6310 6310 2016-09-21 M84963110 Freeman Pancreatic Flexi-Stent Kit 6311 6311 2016-09-21 M84963200 Freeman Pancreatic Flexi-Stent Kit 6320 6320 2016-09-21 M84963210 Freeman Pancreatic Flexi-Stent Kit 6321 6321 2016-09-21 M84965010 Freeman Pancreatic Flexi-Stent Kit 6501 6501 2016-09-21 M84965020 Freeman Pancreatic Flexi-Stent Kit 6502 6502 2016-09-21 M84965030 Freeman Pancreatic Flexi-Stent Kit 6503 6503 2016-09-21 M84965040 Freeman Pancreatic Flexi-Stent Kit 6504 6504 2016-09-21 M84965050 Freeman Pancreatic Flexi-Stent Kit 6505 6505 2016-09-21 M84965060 Freeman Pancreatic Flexi-Stent Kit 6506 6506 2016-09-21
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06959664925645 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-06-18 06959664925676 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-06-18 06959664925584 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664925614 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664925959 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664925980 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926017 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926048 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926314 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926345 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926376 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926406 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926673 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926703 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926734 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926765 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927038 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927069 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927090 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927120 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927403 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927434 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927465 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927496 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664928943 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664928974 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664929001 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664929032 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664929070 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664929100 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15