Duns Number:068199363
Device Description: The Advantage Polyp Trap-Quad Chamber Polyp Trap
Catalog Number
100104
Brand Name
The Advantage Polyp Trap-Quad Chamber Polyp Trap
Version/Model Number
100104
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
c289cd60-ded0-4034-a03f-11cf625dc6b4
Public Version Date
May 26, 2022
Public Version Number
4
DI Record Publish Date
April 30, 2021
Package DI Number
30677964054946
Quantity per Package
50
Contains DI Package
00677964054945
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 |