Duns Number:627879687
Device Description: The single use InStream polyp trap is used for suction retrieval of endoscopically removed
Catalog Number
00711098
Brand Name
InStream
Version/Model Number
00711098
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 17, 2020
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
8c4abf05-9699-4ba2-9884-4f663c0d0f37
Public Version Date
January 08, 2021
Public Version Number
9
DI Record Publish Date
September 17, 2016
Package DI Number
10816765010966
Quantity per Package
50
Contains DI Package
00816765010969
Package Discontinue Date
March 17, 2020
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |