Polyp Pak - The Polyp Pak includes 1 Rotator snare - oval and - US Endoscopy

Duns Number:627879687

Device Description: The Polyp Pak includes 1 Rotator snare - oval and 1 Roth Net retriever - polyp. The Rotat The Polyp Pak includes 1 Rotator snare - oval and 1 Roth Net retriever - polyp. The Rotator snare is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy. The Roth Net retriever 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

00711091

Brand Name

Polyp Pak

Version/Model Number

00711091

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"

-

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

a153257a-7509-400f-a56a-158f6b7f4572

Public Version Date

April 07, 2021

Public Version Number

7

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

10816765010959

Quantity per Package

5

Contains DI Package

00816765010952

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