FDA.reportPublic FDA data

HueRex™ Disposable Stone Retrieval Basket

Primary DI
06970462547341
Brand
HueRex™ Disposable Stone Retrieval Basket
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
BS-3P-5312/11
Published
2026-07-11
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
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
16970462547348PackageGS11In Commercial Distribution
16970462547980PackageGS15In Commercial Distribution
26970462547345PackageGS110In Commercial Distribution
26970462547987PackageGS16In Commercial Distribution
36970462547342PackageGS15In Commercial Distribution
06970462547341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697046254734816970462547348
1697046254798016970462547980
2697046254734526970462547345
2697046254798726970462547987
3697046254734236970462547342
06970462547341069704625473416970462547341

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
403655303
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
06970462547334HueRex™ Disposable Stone Retrieval BasketBS-3P-5312/082026-07-11
06970462547358HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/082026-07-11
06970462547365HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/112026-07-11
06970462547372HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/082026-07-11
06970462547389HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/112026-07-11
06970462547396HueRex™ Disposable Stone Retrieval BasketBS-4P-0612/102026-07-11
06970462547402HueRex™ Disposable Stone Retrieval BasketBS-4P-0612/162026-07-11
06970462546771Single-use Ureteral Access SheathY-10-502025-07-23
06970462546788Single-use Ureteral Access SheathY-11-402025-07-23
06970462546795Single-use Ureteral Access SheathY-11-502025-07-23
06970462546801Single-use Ureteral Access SheathY-12-402025-07-23
06970462546818Single-use Ureteral Access SheathY-12-502025-07-23
06970462547457Single-use Ureteral Access SheathY-08-362026-02-10
06970462547464Single-use Ureteral Access SheathY-08-402026-02-10
06970462547471Single-use Ureteral Access SheathY-08-452026-02-10
06970462547488Single-use Ureteral Access SheathY-08-502026-02-10
06970462547495Single-use Ureteral Access SheathY-08-552026-02-10
06970462547501Single-use Ureteral Access SheathY-09-362026-02-10
06970462547518Single-use Ureteral Access SheathY-09-452026-02-10
06970462547525Single-use Ureteral Access SheathY-09-552026-02-10

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
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
06973356553886TriousShenzhen Trious Medical Technology Co., Ltd.FFL2026-05-09