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
06959664912126NAAG-5099-052022-10-09
06959664925645NAAG-5251-0830212026-06-18
06959664925676NAAG-5251-0830242026-06-18
06959664925584NAAG-5251-0830182026-04-15
06959664925614NAAG-5251-0830192026-04-15
06959664925959NAAG-5251-1055182026-04-15
06959664925980NAAG-5251-1055192026-04-15
06959664926017NAAG-5251-1055212026-04-15
06959664926048NAAG-5251-1055242026-04-15
06959664926314NAAG-5251-1255182026-04-15
06959664926345NAAG-5251-1255192026-04-15
06959664926376NAAG-5251-1255212026-04-15
06959664926406NAAG-5251-1255242026-04-15
06959664926673NAAG-5251-1555182026-04-15
06959664926703NAAG-5251-1555192026-04-15
06959664926734NAAG-5251-1555212026-04-15
06959664926765NAAG-5251-1555242026-04-15
06959664927038NAAG-5251-1855182026-04-15
06959664927069NAAG-5251-1855192026-04-15
06959664927090NAAG-5251-1855212026-04-15

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