FDA.reportPublic FDA data

Trious

Primary DI
06973356555057
Brand
Trious
Company
Shenzhen Trious Medical Technology Co., Ltd.
Model
205W10F40
Published
2026-04-27
Public version status
New
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
06973356555057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973356555057069733565550576973356555057

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral introduction sheathA flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.

Regulatory Flags#

DUNS number
698045520
Device count
1
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
06973356555392Trious231A5TC2026-05-11
06973356553886Trious211F08D02026-05-09
06973356554081Trious222C10E02026-05-09
06973356554449Trious202HH32152026-05-09
06973356554470Trious202HH35152026-04-27
06973356554807Trious206PT20JY2026-04-27
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
06973356557877PUSEN205W11F502025-12-08
06973356557884PUSEN205W12F402025-12-08
06973356557891PUSEN205W12F502025-12-08
06973356557907PUSEN104F150PS2025-12-08

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Primary DI, Brand, Company table
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