FDA.reportPublic FDA data

Disposable Ureteral Stents

Primary DI
06936534343020
Brand
Disposable Ureteral Stents
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-D-JC-6F-26-S
Published
2026-09-22
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
FADStent, Ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251890000Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.2026-02-20FAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936534343020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936534343020069365343430206936534343020

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric ureteral stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.

Regulatory Flags#

DUNS number
544434963
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
06942804744602Single Use Ureteral Access SheathMD-A-AS-11522026-09-22
06942804744619Single Use Ureteral Access SheathMD-A-AS-11532026-09-22
06942804744626Single Use Ureteral Access SheathMD-A-AS-11542026-09-22
06942804744633Single Use Ureteral Access SheathMD-A-AS-11552026-09-22
06942804744640Single Use Ureteral Access SheathMD-A-AS-10362026-09-22
06942804744657Single Use Ureteral Access SheathMD-A-AS-10372026-09-22
06942804744664Single Use Ureteral Access SheathMD-A-AS-10382026-09-22
06942804744671Single Use Ureteral Access SheathMD-A-AS-10392026-09-22
06942804744688Single Use Ureteral Access SheathMD-A-AS-10402026-09-22
06942804744695Single Use Ureteral Access SheathMD-A-AS-10412026-09-22
06942804744701Single Use Ureteral Access SheathMD-A-AS-10422026-09-22
06942804744718Single Use Ureteral Access SheathMD-A-AS-10432026-09-22
06942804744725Single Use Ureteral Access SheathMD-A-AS-10442026-09-22
06942804744732Single Use Ureteral Access SheathMD-A-AS-10462026-09-22
06942804744749Single Use Ureteral Access SheathMD-A-AS-10472026-09-22
06942804744756Single Use Ureteral Access SheathMD-A-AS-10482026-09-22
06942804744763Single Use Ureteral Access SheathMD-A-AS-10492026-09-22
06942804744770Single Use Ureteral Access SheathMD-A-AS-10502026-09-22
06942804744787Single Use Ureteral Access SheathMD-A-AS-10512026-09-22
06942804744794Single Use Ureteral Access SheathMD-A-AS-10522026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942804759149Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759156Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759163Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759170Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759231Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759248Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759255Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759262Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759323Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759330Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759347Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759354Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759415Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759422Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759439Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759446Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759682Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759699Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759705Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759712Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759774Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759781Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759798Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759804Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759866Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759873Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759880Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759897Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759958Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759965Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22