Duns Number:835233107
Device Description: BIPOLAR SEALER 23-312-1 AQM SBS 5.0
Catalog Number
-
Brand Name
Aquamantys™
Version/Model Number
23-312-1
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
K132974
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
efbb9572-9b14-4f90-863c-dc34feee9d86
Public Version Date
April 06, 2020
Public Version Number
1
DI Record Publish Date
March 27, 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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1961 |
| 3 | A medical device with high risk that requires premarket approval | 1 |