FDA.reportPublic FDA data

CRE Wireguided

Primary DI
08714729339366
Brand
CRE Wireguided
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00558430
Device description
Esophageal/Pyloric Wireguided Balloon Dilatation Catheter
Published
2016-09-24
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
CodeName
FDFColonoscope and accessories, flexible/rigid
FDTduodenoscope and accessories, flexible/rigid
KNQDilator, esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDTDuodenoscope And Accessories, Flexible/RigidGastroenterology, Urology2
KNQDilator, EsophagealGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729339366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729339366087147293393668714729339366

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheter, non-medicatedA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729270133Polaris X™M0047000D0M0047000D02016-09-24
08714729270140Polaris X™M0047001D0M0047001D02016-09-24
08714729270164Polaris X™M0047003D0M0047003D02016-09-24
08714729270171Polaris X™M0047004D0M0047004D02016-09-24
08714729270188Polaris X™M0047005D0M0047005D02016-09-24
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936937792432STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792449STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792456STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792463STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792470STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792487STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792494STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937792500STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-29
06936937786646STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792364STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792371STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792388STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792395STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792401STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792418STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792425STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
06959664925645NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
06973786293260Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293284Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293307Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293321Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293222Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
06973786293246Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
07290016992113Aer-O-Scope Disposable ColonoscopeG.I. VIEW LTDFDF2026-05-27
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925584NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15