Torrent - The Torrent irrigation tubing is intended to - US Endoscopy

Duns Number:627879687

Device Description: The Torrent irrigation tubing is intended to provide irrigation via irrigation fluids, suc The Torrent irrigation tubing is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

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More Product Details

Catalog Number

00711562

Brand Name

Torrent

Version/Model Number

00711562

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OCX

Product Code Name

endoscopic irrigation/suction system

Device Record Status

Public Device Record Key

48771ff7-b37d-4a5c-9dfe-d671417ac7cd

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

10816765011635

Quantity per Package

25

Contains DI Package

00816765011638

Package Discontinue Date

March 31, 2020

Package Status

Not in Commercial Distribution

Package Type

Box

"US ENDOSCOPY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 51
2 A medical device with a moderate to high risk that requires special controls. 902