FDA.reportPublic FDA data

VedBasket, Stone Extraction Baskets

Primary DI
16970057573028
Brand
VedBasket, Stone Extraction Baskets
Company
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Model
VDK-BAS-23-200-35-S4-A
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K230598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230598000Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.2023-09-12LQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970057573028PackageGS11In Commercial Distribution
26970057573025PackageGS12In Commercial Distribution
36970057573022PackageGS15In Commercial Distribution
56970057573026PackageGS110In Commercial Distribution
66970057573023PackageGS130In Commercial Distribution
76970057573020PackageGS185In Commercial Distribution
06970057573021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697005757302816970057573028
2697005757302526970057573025
3697005757302236970057573022
5697005757302656970057573026
6697005757302366970057573023
7697005757302076970057573020
06970057573021069700575730216970057573021

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544430136
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
06941513200089Disposable Non-electric Biopsy ForcepsVDK-FB-30-230-O-P1-B12026-05-22
06941513222692Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P-A22026-05-22
06941513222708Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P1-A22026-05-22
06941513222715Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P-A22026-05-22
06941513222722Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A22026-05-22
06970057578248Disposable Cleaning BrushVDK-CB-06-230-C2026-05-22
06970057578286Polyp TrapsVDK-PT-052026-05-22
06970057579023Disposable Grasping ForcepsVDK-FG-23-230-A12026-05-22
06970057571027Stone Extraction BalloonVDK-BAL-23-11/13/15-B2026-04-14
06970057577937Disposable SphincterotomeVDK-KE-3025110-A2026-04-14
06970057579061Disposable Grasping ForcepsVDK-FG-23-230-A42026-03-25
06970057573014VedBasket, Stone Extraction BasketsVDK-BAS-23-200-30-S4-A2024-08-20
06970057575032Disposable Polyp SnareVDK-SD-23-230-35-A12024-08-20
06970057578040Disposable Endoscopic HemoclipVDK-CD-13-230-P2024-08-20
06970057578118Disposable Endoscopic HemoclipVDK-CD-16-230-P2024-08-20
06970057573021VedBasket, Stone Extraction BasketsVDK-BAS-23-200-35-S4-A2024-08-20
06970057578002Disposable Endoscopic HemoclipVDK-CD-11-230-P2024-08-20
06970057574486Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
16970057574483Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
06941513210972Disposable Non-electric Biopsy ForcepsVDK-FB-18-70-O-P-B12025-02-26

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