Catchem' Polyp Trap - Suction system container, 4 chamber - ENDO-THERAPEUTICS, INC.

Duns Number:825239189

Device Description: Suction system container, 4 chamber

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More Product Details

Catalog Number

ET2211

Brand Name

Catchem' Polyp Trap

Version/Model Number

ET2211

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Device Record Status

Public Device Record Key

9603a468-2de7-4c60-8695-4630058e9b5f

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10816207020362

Quantity per Package

12

Contains DI Package

00816207020365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"ENDO-THERAPEUTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 85