FDA.reportPublic FDA data

NA

Primary DI
16959664911959
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5096-0520
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
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGXSnare, Non-ElectricalGastroenterology, Urology1
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664911959PackageGS15In Commercial Distribution
26959664911956PackageGS150In Commercial Distribution
06959664911952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491195916959664911959
2695966491195626959664911956
06959664911952069596649119526959664911952

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
08809909421709CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421716CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421693CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-24
00827002613515SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002613522SureTome SWCOOK INCORPORATEDKNS2025-12-08
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
00827002597501Tesla BicordCOOK INCORPORATEDKNS2025-07-11
00724995243746Exacto MundoUS EndoscopyFGX2025-01-31
00724995226732Padlock ClipUS EndoscopyKNS2024-10-31
08809922260637ELRA ElectrodeSTARMED CO.,LTDKNS2024-08-28
20653405051555APOLLO3Conmed CorporationKNS2024-07-22
20653405051562APOLLO3Conmed CorporationKNS2024-07-22
00816207021324RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021331RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021348RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021355RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021362RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00816207021379RotoNetENDO-THERAPEUTICS, INC.FGX2023-07-11
00851925007885Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.KNS2023-03-08
00816207020969eSuctionENDO-THERAPEUTICS, INC.FGX2022-09-21
00816207020976eSuctionENDO-THERAPEUTICS, INC.FGX2022-09-21
00816207021089SwirlNetENDO-THERAPEUTICS, INC.FGX2022-09-21
00816207021096SwirlNetENDO-THERAPEUTICS, INC.FGX2022-09-21