FDA.reportPublic FDA data

PUSEN

Primary DI
06973356557877
Brand
PUSEN
Company
Shenzhen Trious Medical Technology Co., Ltd.
Model
205W11F50
Published
2025-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243710000Disposable ureteral access sheathShenzhen Trious Medical Technology Co., Ltd.2025-04-11FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973356557877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973356557877069733565578776973356557877

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
698045520
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973356555392Trious231A5TC2026-05-11
06973356553886Trious211F08D02026-05-09
06973356554081Trious222C10E02026-05-09
06973356554449Trious202HH32152026-05-09
06973356554470Trious202HH35152026-04-27
06973356554807Trious206PT20JY2026-04-27
06973356555057Trious205W10F402026-04-27
06973356555385Trious231A5DG2026-04-27
06973356553961Trious211T10D02026-04-22
06973356554777Trious206PT18DG2026-03-27
06973356555422Trious231A6DG2026-03-27
06973356557754Trious104F1502026-03-25
06973356555088Trious205W11F502026-01-16
06973356555163Trious205Y10F452026-01-16
06973356557846PUSEN205W10F402025-12-08
06973356557853PUSEN205W10F502025-12-08
06973356557860PUSEN205W11F402025-12-08
06973356557884PUSEN205W12F402025-12-08
06973356557891PUSEN205W12F502025-12-08
06973356557907PUSEN104F150PS2025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506062514Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062576Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
06942804744602Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744619Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744626Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744633Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744640Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744657Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744664Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744671Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744688Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744695Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744701Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744718Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744725Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744732Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744749Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744756Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744763Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744770Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744787Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744794Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744800Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22