FDA.reportPublic FDA data

NA

Primary DI
06959664913499
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5591-01
Published
2023-03-31
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
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664913496PackageGS125In Commercial Distribution
26959664913493PackageGS150In Commercial Distribution
06959664913499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491349616959664913496
2695966491349326959664913493
06959664913499069596649134996959664913499

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic guidewire holderA device intended to be used during diagnostic and/or therapeutic endoscopy of the gastrointestinal (GI) tract [e.g., endoscopic retrograde cholangiopancreatography (ERCP)] to hold a guidewire in place at a given insertion depth through the working channel of an endoscope. It is typically a small plastic device intended to be attached to the proximal end of the endoscope, with a feature to hold the guidewire in place (e.g., j-slot). This is a single-use device.

Regulatory Flags#

DUNS number
542984702
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664902073NAAG-5335-2410182026-07-22
06959664902097NAAG-5335-2415182026-07-22
06959664902110NAAG-5335-2425182026-07-22
06959664902127NAAG-5335-2425232026-07-22
06959664902134NAAG-5335-2432182026-07-22
06959664902141NAAG-5335-2432232026-07-22
06959664902158NAAG-5336-2410182026-07-22
06959664902172NAAG-5336-2415182026-07-22
06959664902196NAAG-5336-2425182026-07-22
06959664902202NAAG-5336-2425232026-07-22
06959664902219NAAG-5336-2432182026-07-22
06959664902226NAAG-5336-2432232026-07-22
06959664902233NAAG-5337-2410182026-07-22
06959664902240NAAG-5337-2410232026-07-22
06959664902257NAAG-5337-2415182026-07-22
06959664902264NAAG-5337-2415232026-07-22
06959664902271NAAG-5337-2425182026-07-22
06959664902288NAAG-5337-2425232026-07-22
06959664902295NAAG-5337-2432182026-07-22
06959664902301NAAG-5337-2432232026-07-22

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Primary DI, Brand, Company table
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00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
00724995246693DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246709DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246716DEFENDO Biopsy Valve IrrigatorMEDIVATORS INC.ODC2026-04-06
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
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00724995246785Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246846DEFENDO SINGLE USE VALVE KITMEDIVATORS INC.ODC2026-04-06
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04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957910andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
00724995247300NAMEDIVATORS INC.ODC2026-03-02
04897106957835Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957842Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957859Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957866Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
04897106957903Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957927Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
04897106957576andorate® Champion 3-piece Valve KitGA Health Company LimitedODC2025-11-21
04897106957583andorate® Champion 4-piece valve kitGA Health Company LimitedODC2025-11-21
04897106957644Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2025-10-30