Duns Number:016889401
Device Description: FlowPort II Cannula (2) (Smith & Nephew) with Obturator (1)
Catalog Number
STCAT00776
Brand Name
Sustainable Technologies
Version/Model Number
STCAT00776
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
NBH
Product Code Name
Accessories, Arthroscopic
Public Device Record Key
973a61a0-6e47-4ddc-b2bd-98ede69d1407
Public Version Date
June 28, 2021
Public Version Number
3
DI Record Publish Date
December 12, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3993 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1216 |