Duns Number:016889401
Device Description: Aquamantys 6.0 Bipolar Sealer
Catalog Number
ST23-112-1
Brand Name
Sustainable Technologies
Version/Model Number
ST23-112-1
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
K172647
Product Code
NUJ
Product Code Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Public Device Record Key
489d0d56-eee2-4726-b272-2aa091bf5af7
Public Version Date
May 24, 2021
Public Version Number
4
DI Record Publish Date
April 23, 2020
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 |