FDA.reportPublic FDA data

Disposable Ureteral Stents

Primary DI
06936534306209
Brand
Disposable Ureteral Stents
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-C-JC-4.7F-18
Published
2026-09-20
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
06936534306209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936534306209069365343062096936534306209

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
06936534300030Disposable Ureteral StentsMD-C-JC-5F-282026-09-20
06936534300054Disposable Ureteral StentsMD-C-JC-6F-282026-09-20
06936534306070Disposable Ureteral StentsMD-C-JC-4F-142026-09-20
06936534306087Disposable Ureteral StentsMD-C-JC-4.5F-142026-09-20
06936534306094Disposable Ureteral StentsMD-C-JC-4.5F-152026-09-20
06936534306100Disposable Ureteral StentsMD-C-JC-4.5F-162026-09-20
06936534306117Disposable Ureteral StentsMD-C-JC-4.5F-182026-09-20
06936534306124Disposable Ureteral StentsMD-C-JC-4.5F-202026-09-20
06936534306131Disposable Ureteral StentsMD-C-JC-4.5F-222026-09-20
06936534306148Disposable Ureteral StentsMD-C-JC-4.5F-242026-09-20
06936534306155Disposable Ureteral StentsMD-C-JC-4.5F-262026-09-20
06936534306162Disposable Ureteral StentsMD-C-JC-4.5F-282026-09-20
06936534306179Disposable Ureteral StentsMD-C-JC-4.7F-142026-09-20
06936534306186Disposable Ureteral StentsMD-C-JC-4.7F-152026-09-20
06936534306193Disposable Ureteral StentsMD-C-JC-4.7F-162026-09-20
06936534306216Disposable Ureteral StentsMD-C-JC-4.7F-202026-09-20
06936534306223Disposable Ureteral StentsMD-C-JC-4.7F-222026-09-20
06936534306230Disposable Ureteral StentsMD-C-JC-4.7F-242026-09-20
06936534306247Disposable Ureteral StentsMD-C-JC-4.7F-262026-09-20
06936534306254Disposable Ureteral StentsMD-C-JC-4.7F-282026-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936534300030Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534300054Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306070Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306087Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306094Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306100Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306117Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306124Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306131Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306148Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306155Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306162Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306179Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306186Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306193Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306216Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306223Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306230Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306247Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306254Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306261Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306278Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306285Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306292Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306308Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306315Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306322Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306339Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306353Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20
06936534306360Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-20