Roth Net - The disposable Roth Net foreign body mini - US Endoscopy

Duns Number:627879687

Device Description: The disposable Roth Net foreign body mini retrieval device is used in the endoscopic retri The disposable Roth Net foreign body mini retrieval device is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.

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More Product Details

Catalog Number

00711057

Brand Name

Roth Net

Version/Model Number

00711057

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 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

Yes

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

FDI

Product Code Name

SNARE, FLEXIBLE

Device Record Status

Public Device Record Key

0aeb7292-a749-4d77-b045-5a64ce4ae4a8

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

10816765010898

Quantity per Package

5

Contains DI Package

00816765010891

Package Discontinue Date

March 17, 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