Duns Number:627879687
Device Description: The single use eTrap – polyp trap is used for suction retrieval of endoscopically removed The single use eTrap – polyp trap is used for suction retrieval of endoscopically removed polyps.
Catalog Number
00711099
Brand Name
eTrap
Version/Model Number
00711099
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"
Yes
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
4c038360-bce3-4c57-8519-2d355bd23e5a
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
March 19, 2020
Package DI Number
10724995184725
Quantity per Package
25
Contains DI Package
00724995184728
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |