Catchem' Polyp Trap - Suction system canister, 2 chamber - ENDO-THERAPEUTICS, INC.

Duns Number:825239189

Device Description: Suction system canister, 2 chamber

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More Product Details

Catalog Number

ET2210

Brand Name

Catchem' Polyp Trap

Version/Model Number

ET2210

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2019

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

e096b4ec-a646-45d6-9061-ee9c0eb5364f

Public Version Date

January 08, 2021

Public Version Number

7

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10816207020355

Quantity per Package

25

Contains DI Package

00816207020358

Package Discontinue Date

November 04, 2019

Package Status

Not 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