FDA.reportPublic FDA data

NA

Primary DI
16959664913496
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5591-01
Published
2023-03-31
Public version status
New
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
FGXSnare, Non-Electrical
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGXSnare, Non-ElectricalGastroenterology, Urology1
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
Mechanical-cutting endoscopic polypectomy snareA sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542984702
Device count
1
DM exempt
false
Premarket exempt
true
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664905203NAAG-50114-23122026-05-15
06959664905210NAAG-50114-23162026-05-15
06959664905227NAAG-50114-23182026-05-15
06959664905234NAAG-50114-23202026-05-15
06959664905241NAAG-50114-23232026-05-15
06959664905258NAAG-50114-23272026-05-15
06959664905265NAAG-50115-23072026-05-15
06959664905272NAAG-50115-23122026-05-15
06959664905289NAAG-50115-23162026-05-15
06959664905296NAAG-50115-23182026-05-15
06959664905302NAAG-50115-23202026-05-15
06959664905319NAAG-50115-23232026-05-15
06959664905326NAAG-50115-23272026-05-15
06959664905333NAAG-50115-18072026-05-15
06959664905340NAAG-50115-18122026-05-15
06959664905357NAAG-50115-18162026-05-15
06959664905364NAAG-50115-18182026-05-15
06959664905371NAAG-50115-18202026-05-15
06959664905388NAAG-50115-18232026-05-15
06959664905395NAAG-50115-18272026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421457SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421464SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421471SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421488SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
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
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
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
00724995247300NAMEDIVATORS INC.ODC2026-03-02
46932503554518EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
46932503554525EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
00724995243753Exacto MundoUS EndoscopyFGX2025-08-19
00724995243760Exacto MundoUS EndoscopyFGX2025-08-19
00858276007984Endoscopy Kit - Compliance+ FUJ5 KitMicro-tech UsaODC2025-05-12
008500258605674-Piece Valve KitMicro-tech UsaODC2025-03-04
00850025860642Auxiliary Water ConnectorMicro-tech UsaODC2025-03-04
00850025860659Auxiliary Water ConnectorMicro-tech UsaODC2025-03-04
00850025860673Auxiliary Water ConnectorMicro-tech UsaODC2025-03-04
008500258606805-Piece Valve KitMicro-tech UsaODC2025-03-04
008500258607104-Piece Valve KitMicro-tech UsaODC2025-03-04