Duns Number:068199363
Device Description: EcoNotrap 1 Single Chamber Polyp Trap
Catalog Number
100101
Brand Name
EcoNotrap 1 Single Chamber Polyp Trap
Version/Model Number
100101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 25, 2022
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)
-
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
8dc4b49a-f266-4abc-8167-6e60dea64b41
Public Version Date
May 26, 2022
Public Version Number
4
DI Record Publish Date
April 30, 2021
Package DI Number
10677964054928
Quantity per Package
50
Contains DI Package
00677964054921
Package Discontinue Date
May 25, 2022
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 | 2999 |
2 | A medical device with a moderate to high risk that requires special controls. | 362 |