FDA.reportPublic FDA data

Wellead Stone Retrieval Basket

Primary DI
06936881136818
Brand
Wellead Stone Retrieval Basket
Company
Well Lead Medical Co.,Ltd
Model
U04B010710
Device description
SB4NS-18090
Published
2023-07-12
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
FFLDislodger, Stone, Basket, Ureteral, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFLDislodger, Stone, Basket, Ureteral, MetalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936881136815PackageGS11In Commercial Distribution
26936881136812PackageGS110In Commercial Distribution
06936881136818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693688113681516936881136815
2693688113681226936881136812
06936881136818069368811368186936881136818

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.

Regulatory Flags#

DUNS number
544811862
Device count
1
Premarket exempt
true
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
06925816656057Suction CatheterFN02A0606202026-06-03
06925816673962Wellead Hydrophilic Intermittent Catheter F01L0308302026-04-03
06925816673979Wellead Hydrophilic Intermittent Catheter F01L0310302026-04-03
06925816673986Wellead Hydrophilic Intermittent Catheter F01L0312302026-04-03
06925816673993Wellead Hydrophilic Intermittent Catheter F01L0314302026-04-03
06925816674006Wellead Hydrophilic Intermittent Catheter F01L0316302026-04-03
06925816674013Wellead Hydrophilic Intermittent Catheter F01L0318302026-04-03
06925816674020Wellead Hydrophilic Intermittent Catheter F01L0208202026-04-03
06925816674037Wellead Hydrophilic Intermittent Catheter F01L0210202026-04-03
06925816674044Wellead Hydrophilic Intermittent Catheter F01L0212202026-04-03
06925816674051Wellead Hydrophilic Intermittent Catheter F01L0214202026-04-03
06925816674068Wellead Hydrophilic Intermittent Catheter F01L0216202026-04-03
06925816674075Wellead Hydrophilic Intermittent Catheter F01L0218202026-04-03
06925816674082Wellead Hydrophilic Intermittent Catheter F01L0410302026-04-03
06925816674099Wellead Hydrophilic Intermittent Catheter F01L0412302026-04-03
06925816674105Wellead Hydrophilic Intermittent Catheter F01L0414302026-04-03
06925816674112Wellead Hydrophilic Intermittent Catheter F01L0416302026-04-03
06925816674129Wellead Hydrophilic Intermittent Catheter F01L0418302026-04-03
06925816674136Wellead Hydrophilic Intermittent Catheter F01L0108102026-04-03
06925816674143Wellead Hydrophilic Intermittent Catheter F01L0110102026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970462547334HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547341HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547358HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547365HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547372HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547389HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547396HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547402HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06976358502845SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502852SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502869SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502876SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502883SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502890SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502906SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502913SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502920SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502937SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502944SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502951SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502968SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502975SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502982SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502999SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503002SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503019SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503026SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503033SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503040SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503057SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14