FDA.reportPublic FDA data

NA

Primary DI
06959664931974
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5311-2416-2106M
Device description
the Catheter OD is 2.4mm, working length is 1600mm, model of needle is 21, needle extension length is 6 mm, the headend type is metal cap.
Published
2021-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FBKEndoscopic Injection Needle, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190032000Disposable Sclerotherapy NeedleHangzhou AGS MedTech Co., Ltd.2020-02-27FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664931971PackageGS110In Commercial Distribution
26959664931978PackageGS1100In Commercial Distribution
06959664931974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966493197116959664931971
2695966493197826959664931978
06959664931974069596649319746959664931974

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
542984702
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664900093NAAG-5051-2317-13-15-182026-07-17
06959664900208NAAG-5051-2317-182026-07-17
06959664901069NAAG-5091-05252026-07-17
06959664901076NAAG-5091-05302026-07-17
06959664901137NAAG-5051-2317-122026-07-17
06959664901441NAAG-5051-2317-152026-07-17
06959664901458NAAG-5053-2317-152026-07-17
06959664901595NAAG-5091-15252026-07-17
06959664901663NAAG-5093-05202026-07-17
06959664901687NAAG-5093-05252026-07-17
06959664901700NAAG-5093-05302026-07-17
06959664901717NAAG-5094-052026-07-17
06959664902578NAAG-5053-2317-13-15-182026-07-17
06959664902646NAAG-5093-15202026-07-17
06959664902653NAAG-5051-2317-85-12-152026-07-17
06959664902660NAAG-5051-2317-852026-07-17
06959664903247NAAG-5053-2317-122026-07-17
06959664903254NAAG-5053-2317-182026-07-17
06959664903261NAAG-5053-2317-85-12-152026-07-17
06959664903520NAAG-5091-05202026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850002461388InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461395InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461418InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461425InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
00850002461404InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
00850002461435InjecSURE®Carbon Medical Technologies, Inc.FBK2026-04-09
03600040326893BoNeeColoplast A/SFBK2025-05-20
03600040974841BoNeeColoplast A/SFBK2025-05-20
00816734023365EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023372EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023389EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023396EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816207021256AcuJect FlexENDO-THERAPEUTICS, INC.FBK2023-07-11
00860008483720Uro-N CystoscopeUROVIU CORP.FBK2022-12-16
00724995219185FastFloUS EndoscopyFBK2022-11-09
00724995219192FastFloUS EndoscopyFBK2022-11-09
00724995219208FastFloUS EndoscopyFBK2022-11-09
00724995219215FastFloUS EndoscopyFBK2022-11-09
00724995180881NAUS EndoscopyFBK2020-04-02
00724995180898NAUS EndoscopyFBK2020-04-02
00724995180904NAUS EndoscopyFBK2020-04-02
00724995180911NAUS EndoscopyFBK2020-04-02
00724995180928NAUS EndoscopyFBK2020-04-02
00724995180935NAUS EndoscopyFBK2020-04-02
00724995180942NAUS EndoscopyFBK2020-04-02
00724995180850ArticulatorUS EndoscopyFBK2020-04-01
00724995180867ArticulatorUS EndoscopyFBK2020-04-01
00724995180874ArticulatorUS EndoscopyFBK2020-04-01
00724995180782iSnareUS EndoscopyFBK2020-03-19
00724995180799iSnareUS EndoscopyFBK2020-03-19