Tornus ES

GUDID 04547327156493

ASAHI INTECC CO., LTD.

Endoscopic-access dilator, single-use
Primary Device ID04547327156493
NIH Device Record Keybe7d911e-97fd-4ea6-bb91-68b0f88a5896
Commercial Distribution StatusIn Commercial Distribution
Brand NameTornus ES
Version Model NumberTES0025S
Company DUNS690711189
Company NameASAHI INTECC CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French
Length195 Centimeter
Catheter Gauge7 French

Device Identifiers

Device Issuing AgencyDevice ID
GS104547327156493 [Primary]

FDA Product Code

FGEStents, drains and dilators for the biliary ducts

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-05
Device Publish Date2025-01-28

On-Brand Devices [Tornus ES]

04547327156509TES0018S
04547327156493TES0025S

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