FDA.reportPublic FDA data

NA

Primary DI
06959664926765
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5251-155524
Published
2026-04-15
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
CodeName
FDFColonoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid
FGEStents, Drains And Dilators For The Biliary Ducts
KNQDilator, Esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2
KNQDilator, EsophagealGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664926762PackageGS15In Commercial Distribution
26959664926769PackageGS110In Commercial Distribution
06959664926765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966492676216959664926762
2695966492676926959664926769
06959664926765069596649267656959664926765

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.

Regulatory Flags#

DUNS number
542984702
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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664900741NAAG-5062-N20242026-08-03
06959664900758NAAG-5062-N25242026-08-03
06959664900796NAAG-5063-S20242026-08-03
06959664900802NAAG-5063-S25242026-08-03
06959664900819NAAG-5063-S2024G2026-08-03
06959664900826NAAG-5063-S3024G2026-08-03
06959664901465NAAG-5061-N20242026-08-03
06959664901472NAAG-5061-N25242026-08-03
06959664903568NAAG-5063-S30242026-08-03
06959664903575NAAG-5061-N30242026-08-03
06959664903582NAAG-5061-N20182026-08-03
06959664903599NAAG-5061-N10182026-08-03
06959664903605NAAG-5062-N30242026-08-03
06959664903629NAAG-5062-N10182026-08-03
06959664903797NAAG-5062-N20182026-08-03
06959664907597NAAG-5061-N25182026-08-03
06959664907603NAAG-5061-N30182026-08-03
06959664907610NAAG-5062-N25182026-08-03
06959664907627NAAG-5062-N30182026-08-03
06959664910672NAAG-5061-N3024G2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902170191ARROWTELEFLEX INCORPORATEDFGE2026-08-03
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
04052838002400Endoflux™Medi-Globe GmbHFGE2026-07-20
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
04961333246779PENTAXHOYA CORPORATIONFDF2025-04-04
04961333246830PENTAXHOYA CORPORATIONFDF2025-04-04
04961333246847PENTAXHOYA CORPORATIONFDS2025-04-04
04961333246939PENTAXHOYA CORPORATIONFDS2025-04-04
04961333254644PENTAX MedicalHOYA CORPORATIONFDS2024-12-13
04961333254644PENTAX MedicalHOYA CORPORATIONFDF2024-12-13
04961333254668PENTAX MedicalHOYA CORPORATIONFDF2024-12-13
04961333254668PENTAX MedicalHOYA CORPORATIONFDS2024-12-13
04961333254620PENTAX MedicalHOYA CORPORATIONFDF2024-12-13
04961333254620PENTAX MedicalHOYA CORPORATIONFDS2024-12-13
04961333254316PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254323PENTAXHOYA CORPORATIONFDF2024-07-26