Duns Number:544333811
Device Description: It is used for suction retrieval of endoscopically removed polyps.
Catalog Number
-
Brand Name
Andorate ThomasTrap
Version/Model Number
GAR040
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 27, 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"
Yes
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
CBC
Product Code Name
Bottle, Collection And Trap, Breathing System (Uncalibrated)
Public Device Record Key
e7d53950-7e76-4eb2-8435-187240a614eb
Public Version Date
October 27, 2022
Public Version Number
5
DI Record Publish Date
October 23, 2018
Package DI Number
16970934720118
Quantity per Package
20
Contains DI Package
06970934720111
Package Discontinue Date
December 27, 2019
Package Status
Not in Commercial Distribution
Package Type
Outerbox
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |