FDA.reportPublic FDA data

NA

Primary DI
06959664909560
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5332-241523
Published
2019-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGXSnare, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGXSnare, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664909567PackageGS110In Commercial Distribution
26959664909564PackageGS110In Commercial Distribution
36959664909561PackageGS12Not in Commercial Distribution
46959664909568PackageGS125Not in Commercial Distribution
56959664909565PackageGS15Not in Commercial Distribution
66959664909562PackageGS110Not in Commercial Distribution
06959664909560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966490956716959664909567
2695966490956426959664909564
3695966490956136959664909561
4695966490956846959664909568
5695966490956556959664909565
6695966490956266959664909562
06959664909560069596649095606959664909560

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664912126NAAG-5099-052022-10-09
06959664925645NAAG-5251-0830212026-06-18
06959664925676NAAG-5251-0830242026-06-18
06959664925584NAAG-5251-0830182026-04-15
06959664925614NAAG-5251-0830192026-04-15
06959664925959NAAG-5251-1055182026-04-15
06959664925980NAAG-5251-1055192026-04-15
06959664926017NAAG-5251-1055212026-04-15
06959664926048NAAG-5251-1055242026-04-15
06959664926314NAAG-5251-1255182026-04-15
06959664926345NAAG-5251-1255192026-04-15
06959664926376NAAG-5251-1255212026-04-15
06959664926406NAAG-5251-1255242026-04-15
06959664926673NAAG-5251-1555182026-04-15
06959664926703NAAG-5251-1555192026-04-15
06959664926734NAAG-5251-1555212026-04-15
06959664926765NAAG-5251-1555242026-04-15
06959664927038NAAG-5251-1855182026-04-15
06959664927069NAAG-5251-1855192026-04-15
06959664927090NAAG-5251-1855212026-04-15

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
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
56932503554515EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
56932503554522EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
00724995243753Exacto MundoUS EndoscopyFGX2025-08-19
00724995243760Exacto MundoUS EndoscopyFGX2025-08-19
10724995243750Exacto MundoUS EndoscopyFGX2025-08-19
10724995243767Exacto MundoUS EndoscopyFGX2025-08-19
06932503554510EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
06932503554527EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
16932503554517EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
16932503554524EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
00724995243746Exacto MundoUS EndoscopyFGX2025-01-31
10724995243743Exacto MundoUS EndoscopyFGX2025-01-31
06936603226971Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06936603226988Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06936603227015Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06936603227022Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06941513202243Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
06941513202250Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
06941513202274Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
06941513202281Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202240Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202257Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202271Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202288Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07