FDA.reportPublic FDA data

NA

Primary DI
06959664926406
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5251-125524
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
16959664926403PackageGS15In Commercial Distribution
26959664926400PackageGS110In Commercial Distribution
06959664926406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966492640316959664926403
2695966492640026959664926400
06959664926406069596649264066959664926406

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
06959664944677NAAG-5033-14162026-08-21
06959664900086NAAG-51061-1650-090-92026-08-19
06959664900178NAAG-51061-1800-090-92026-08-19
06959664900185NAAG-51061-1950-090-92026-08-19
06959664900192NAAG-51061-2150-090-92026-08-19
06959664900291NAAG-51061-2300-090-92026-08-19
06959664900307NAAG-51061-1650-135-92026-08-19
06959664900314NAAG-51061-1800-135-92026-08-19
06959664900543NAAG-51061-1950-135-92026-08-19
06959664900550NAAG-51061-2150-135-92026-08-19
06959664900574NAAG-51061-2300-135-92026-08-19
06959664900598NAAG-51063-1650-090-132026-08-19
06959664900635NAAG-51063-1800-090-132026-08-19
06959664900666NAAG-51063-1950-090-132026-08-19
06959664900697NAAG-51063-1950-090-132026-08-19
06959664900840NAAG-51063-1950-090-132026-08-19
06959664900864NAAG-51063-1650-135-132026-08-19
06959664900871NAAG-51063-1800-135-132026-08-19
06959664900888NAAG-51063-1950-135-132026-08-19
06959664900895NAAG-51063-2150-135-132026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002448Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002455Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002462Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002479Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002486Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002493Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002509Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002516Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002523Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002530Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002547Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002554Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002561Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002578Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002585Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002592Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002608Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002615Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002622Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002639Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002646Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002653Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002660Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002677Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002684Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002691Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002707Endoflux™Medi-Globe GmbHFGE2026-08-27