FDA.reportPublic FDA data

Single-use Extraction Baskets

Primary DI
06971381252828
Brand
Single-use Extraction Baskets
Company
Scivita Medical Technology Co., Ltd.
Model
EBF-2029SG
Device description
The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended for the endoscopic removal of stones and stone fragments in the biliary system.
Published
2024-12-06
Public version status
Update
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
K240192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240192000Single-use Extraction BasketsScivita Medical Technology Co., Ltd.2024-10-15LQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971381252825PackageGS136In Commercial Distribution
06971381252828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697138125282516971381252825
06971381252828069713812528286971381252828

GMDN Terms#

Term, Definition table
TermDefinition
Urinary stone retrieval basket, single-useA manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Regulatory Flags#

DUNS number
544519831
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971381254228Single-use Flexible UreteroscopeSUV-2C-B2026-07-16
06971381252736Single-use Extraction BasketsEBF-1529CG2024-12-06
06971381252743Single-use Extraction BasketsEBF-1511CG2024-12-06
06971381252750Single-use Extraction BasketsEBF-1511SG2024-12-06
06971381252767Single-use Extraction BasketsEBF-1506SG2024-12-06
06971381252774Single-use Extraction BasketsEBF-1506CG2024-12-06
06971381252781Single-use Extraction BasketsEBF-1507SG2024-12-06
06971381252798Single-use Extraction BasketsEBF-1507CG2024-12-06
06971381252804Single-use Extraction BasketsEBF-1508SG2024-12-06
06971381252811Single-use Extraction BasketsEBF-1508CG2024-12-06
06971381252835Single-use Extraction BasketsEBF-2029CG2024-12-06
06971381252903Single-use Extraction BasketsEBF-2006SG2024-12-06
06971381252910Single-use Extraction BasketsEBF-2006CG2024-12-06
06971381252927Single-use Extraction BasketsEBF-2007SG2024-12-06
06971381252934Single-use Extraction BasketsEBF-2007CG2024-12-06
06971381252941Single-use Extraction BasketsEBF-2008SG2024-12-06
06971381252958Single-use Extraction BasketsEBF-2008CG2024-12-06
06971381252729Single-use Extraction BasketsEBF-1529SG2024-12-06
06971381253146Single-use Biopsy ForcepsBFUW-1029P-YG2023-12-28
06971381253153Single-use Biopsy ForcepsBFTW-1629E-YG2023-12-28

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
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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
06959664912188NAHangzhou 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