FDA.reportPublic FDA data

NA

Primary DI
06959664912188
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5065-N1518
Published
2026-08-03
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
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
16959664912185PackageGS110In Commercial Distribution
26959664912182PackageGS110In Commercial Distribution
06959664912188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491218516959664912185
2695966491218226959664912182
06959664912188069596649121886959664912188

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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664900741NAAG-5062-N20242026-08-03
06959664900758NAAG-5062-N25242026-08-03
06959664900796NAAG-5063-S20242026-08-03
06959664900802NAAG-5063-S25242026-08-03
06959664900819NAAG-5063-S2024G2026-08-03
06959664900826NAAG-5063-S3024G2026-08-03
06959664901465NAAG-5061-N20242026-08-03
06959664901472NAAG-5061-N25242026-08-03
06959664903568NAAG-5063-S30242026-08-03
06959664903575NAAG-5061-N30242026-08-03
06959664903582NAAG-5061-N20182026-08-03
06959664903599NAAG-5061-N10182026-08-03
06959664903605NAAG-5062-N30242026-08-03
06959664903629NAAG-5062-N10182026-08-03
06959664903797NAAG-5062-N20182026-08-03
06959664907597NAAG-5061-N25182026-08-03
06959664907603NAAG-5061-N30182026-08-03
06959664907610NAAG-5062-N25182026-08-03
06959664907627NAAG-5062-N30182026-08-03
06959664910672NAAG-5061-N3024G2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664900741NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900758NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900796NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900802NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900819NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900826NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664901465NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664901472NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903568NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903575NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903582NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903599NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903605NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903629NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903797NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907597NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907603NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907610NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907627NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664910672NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911310NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911327NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911556NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911563NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911570NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912171NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912195NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912201NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912218NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912225NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03