FDA.reportPublic FDA data

NA

Primary DI
06959664900772
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5062-N2524G
Published
2022-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LQRDislodger, Stone, Biliary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQRDislodger, Stone, BiliaryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201509000Disposable Stone Extraction basketHangzhou AGS MedTech Co., Ltd.2020-12-16LQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664900779PackageGS110In Commercial Distribution
26959664900776PackageGS1100In Commercial Distribution
06959664900772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966490077916959664900779
2695966490077626959664900776
06959664900772069596649007726959664900772

GMDN Terms#

Term, Definition table
TermDefinition
Biliary/urinary stone retrieval basket, single-useA flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.

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
06959664900925NAAG-5104-2300-1352018-05-28
06959664902684NAAG-5104-2300-135-162018-05-28
06959664902691NAAG-51044-2300-135-162022-10-09
06959664902981NAAG-5104-2300-135-162018-05-28
06959664902998NAAG-51018-2300-135-132022-10-09
06959664903001NAAG-5104-2300-090AG6.510E.0493.000.Z2018-05-28
06959664903100NAAG-5104-2300-090AG6.510E.0403.000.Z2018-05-28
06959664903131NAAG-5104-2300-01352018-05-28
06959664903971NAAG-5108-2300-135-92022-10-09
06959664904190NAAG-5104-2300-090-16AG6.510E.4403.000.Z2018-05-28
06959664911747NAAG-5104-2300-090-16AG6.510E.4493.000.Z2018-05-28
06959664914069NAAG-5101-2300-1352022-10-09
06959664915141NAAG-51041-2300-135-162022-10-09
06959664922583NAAG-51054-2300-135-182022-10-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503511414Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511421Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511438Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511513Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511520Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511537Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511544Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511551Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511568Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511575Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511582Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511599Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511605Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511612Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511629Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511711eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511728eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511735eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511742eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511759eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511766eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511773eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511780eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511797eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511803eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511810eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511827eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511834eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511841eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511858eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28