Duns Number:825239189
Device Description: Suction system canister, 2 chamber
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
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
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
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
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 |