FDA.reportPublic FDA data

NA

Primary DI
06959664910948
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5075-241523
Published
2019-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDISnare, Flexible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664910945PackageGS110In Commercial Distribution
26959664910942PackageGS110In Commercial Distribution
36959664910949PackageGS12Not in Commercial Distribution
46959664910946PackageGS125Not in Commercial Distribution
56959664910943PackageGS15Not in Commercial Distribution
66959664910940PackageGS110Not in Commercial Distribution
06959664910948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491094516959664910945
2695966491094226959664910942
3695966491094936959664910949
4695966491094646959664910946
5695966491094356959664910943
6695966491094066959664910940
06959664910948069596649109486959664910948

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
542984702
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664913482NAAG-55501-1800-090-132026-07-16
06959664915387NAAG-55501-1650-090-112026-07-16
06959664915394NAAG-55501-1650-090-132026-07-16
06959664915400NAAG-55501-1650-090-162026-07-16
06959664915417NAAG-55501-1650-090-92026-07-16
06959664915424NAAG-55501-1650-135-112026-07-16
06959664915431NAAG-55501-1650-135-132026-07-16
06959664915448NAAG-55501-1650-135-162026-07-16
06959664915455NAAG-55501-1650-135-92026-07-16
06959664915462NAAG-55501-1950-090-112026-07-16
06959664915479NAAG-55501-1950-090-132026-07-16
06959664915493NAAG-55501-1950-090-92026-07-16
06959664915509NAAG-55501-1950-135-112026-07-16
06959664915516NAAG-55501-1950-135-132026-07-16
06959664915523NAAG-55501-1950-135-162026-07-16
06959664915530NAAG-55501-1950-135-92026-07-16
06959664915547NAAG-55501-2300-090-112026-07-16
06959664915554NAAG-55501-2300-090-132026-07-16
06959664915561NAAG-55501-2300-090-162026-07-16
06959664915578NAAG-55501-2300-090-92026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995247317SmartBand EMR KitUS EndoscopyFDI2025-11-21
00724995247324SmartBand EMR PackUS EndoscopyFDI2025-11-21
00724995220051Roth NetUS EndoscopyFDI2024-11-25
00724995220068Roth Net PlatinumUS EndoscopyFDI2024-11-25
00724995194369CoinTipUS EndoscopyFDI2020-06-11
00724995194376CoinTipUS EndoscopyFDI2020-06-11
00724995194383CoinTipUS EndoscopyFDI2020-06-11
00724995182878HistolockUS EndoscopyFDI2020-04-02
00724995182908Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182915Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182922Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182939Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995180782iSnareUS EndoscopyFDI2020-03-19
00724995180799iSnareUS EndoscopyFDI2020-03-19
00724995180805iSnareUS EndoscopyFDI2020-03-19
00724995180812iSnareUS EndoscopyFDI2020-03-19
00724995180829iSnareUS EndoscopyFDI2020-03-19
00724995182472Short ThrowUS EndoscopyFDI2020-03-19
00724995182489Short ThrowUS EndoscopyFDI2020-03-19
00724995182496Roth NetUS EndoscopyFDI2020-03-19
00724995182502Roth NetUS EndoscopyFDI2020-03-19
00724995182519Roth NetUS EndoscopyFDI2020-03-19
00724995182526Roth NetUS EndoscopyFDI2020-03-19
00724995182533Roth NetUS EndoscopyFDI2020-03-19
00724995182540Polyp PakUS EndoscopyFDI2020-03-19
00724995182571LariatUS EndoscopyFDI2020-03-19
00724995182588LariatUS EndoscopyFDI2020-03-19
00724995182595Short ThrowUS EndoscopyFDI2020-03-19
00724995182601TraxtionUS EndoscopyFDI2020-03-19
00724995182625HistolockUS EndoscopyFDI2020-03-19