Duns Number:066087031
Device Description: Suction Connection Tubing, 2 meters, 1/4 inch internal diameter, Sterile
Catalog Number
STS16202
Brand Name
Endure
Version/Model Number
STS162021217
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
BYY
Product Code Name
Tube, Aspirating, Flexible, Connecting
Public Device Record Key
4475f73d-9861-48aa-b974-5d56eba722ae
Public Version Date
June 08, 2021
Public Version Number
5
DI Record Publish Date
February 20, 2018
Package DI Number
B531STS162022
Quantity per Package
50
Contains DI Package
B531STS162020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |