Home GUDID 16959664932121 NA
Primary DI 16959664932121
Brand NA
Company Hangzhou AGS MedTech Co., Ltd.
Model AG-5311-2416-2204M
Device description the Catheter OD is 2.4mm, working length is 1600mm, model of needle is 22, needle extension length is 4 mm, the headend type is metal cap
Published 2021-12-06
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 Code Name FBK Endoscopic Injection Needle, Gastroenterology-Urology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 16959664932121 Package GS1 10 In Commercial Distribution 26959664932128 Package GS1 100 In Commercial Distribution 06959664932124 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 16959664932121 16959664932121 26959664932128 26959664932128 06959664932124 06959664932124 6959664932124
GMDN Terms# Term, Definition table Term Definition General-purpose endoscopic needle, single-use A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.
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 false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10850002461388 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 10850002461395 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 10850002461418 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 10850002461425 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 00850002461404 InjecSURE ® Carbon Medical Technologies, Inc. FBK 2026-04-09 00850002461435 InjecSURE® Carbon Medical Technologies, Inc. FBK 2026-04-09 03600040326893 BoNee Coloplast A/S FBK 2025-05-20 03600040974841 BoNee Coloplast A/S FBK 2025-05-20 00816734023365 EZ-Ject DIVERSATEK HEALTHCARE, INC. FBK 2024-07-18 00816734023372 EZ-Ject DIVERSATEK HEALTHCARE, INC. FBK 2024-07-18 00816734023389 EZ-Ject DIVERSATEK HEALTHCARE, INC. FBK 2024-07-18 00816734023396 EZ-Ject DIVERSATEK HEALTHCARE, INC. FBK 2024-07-18 00816207021256 AcuJect Flex ENDO-THERAPEUTICS, INC. FBK 2023-07-11 00860008483720 Uro-N Cystoscope UROVIU CORP. FBK 2022-12-16 00724995219185 FastFlo US Endoscopy FBK 2022-11-09 00724995219192 FastFlo US Endoscopy FBK 2022-11-09 00724995219208 FastFlo US Endoscopy FBK 2022-11-09 00724995219215 FastFlo US Endoscopy FBK 2022-11-09 00724995180881 NA US Endoscopy FBK 2020-04-02 00724995180898 NA US Endoscopy FBK 2020-04-02 00724995180904 NA US Endoscopy FBK 2020-04-02 00724995180911 NA US Endoscopy FBK 2020-04-02 00724995180928 NA US Endoscopy FBK 2020-04-02 00724995180935 NA US Endoscopy FBK 2020-04-02 00724995180942 NA US Endoscopy FBK 2020-04-02 00724995180850 Articulator US Endoscopy FBK 2020-04-01 00724995180867 Articulator US Endoscopy FBK 2020-04-01 00724995180874 Articulator US Endoscopy FBK 2020-04-01 00724995180782 iSnare US Endoscopy FBK 2020-03-19 00724995180799 iSnare US Endoscopy FBK 2020-03-19