Duns Number:544434963
Device Description: EO sterile
Catalog Number
MDPT1B0001A
Brand Name
Polyp Trap
Version/Model Number
MD-B-PT04
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
9661154c-4866-4242-9282-e9949b61960d
Public Version Date
July 18, 2022
Public Version Number
6
DI Record Publish Date
January 09, 2019
Package DI Number
26970401813753
Quantity per Package
5
Contains DI Package
16970401813749
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 147 |