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Tornus ES

FDA UDI

Class II (US FDA UDI)

by Asahi Intecc Co., Ltd.

Identity

Trade Name
Tornus ES FDA UDI
Generic Name
Endoscopic-access dilator, single-use FDA UDI
Model / Reference
TES0025S FDA UDI

Identifiers

Primary DI / UDI-DI
04547327156493 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Endoscopic-access dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 195 Centimeter FDA UDI
Catheter Gauge — 7 French FDA UDI

Category: Endoscopic-access dilator, single-use

Tornus ES by Asahi Intecc Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic-access dilator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.

Sources (1)

  • FDA UDI be7d911e-97fd-4ea6-bb91-68b0f88a5896 33 fields · synced Jun 8, 2026