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TwoVu

FDA UDI

Class I (US FDA UDI)

by Cannuflow, Inc.

Identity

Trade Name
TwoVu FDA UDI
Generic Name
Surgical irrigation/aspiration cannula, non-illuminating, single-use FDA UDI
Device Name
Outflow Sheath FDA UDI
Model / Reference
ST-5 FDA UDI
Description
Outflow Sheath FDA UDI

Identifiers

Catalog Number
TVST-5 FDA UDI
Primary DI / UDI-DI
00866497000349 FDA UDI
FDA Product Code
FGY FDA UDI
GMDN Term
Surgical irrigation/aspiration cannula, non-illuminating, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.5 Millimeter FDA UDI
Length — 113 Millimeter FDA UDI

Category: Surgical irrigation/aspiration cannula, non-illuminating, single-use

TwoVu by Cannuflow, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration cannula, non-illuminating, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cannuflow, Inc.

Sources (1)

  • FDA UDI c1bb6c9d-b5e6-499a-80d4-e165f5c8498e 35 fields · synced Jun 8, 2026