Duns Number:030200852
Device Description: BIPO SEALER 23-318-1 AQM3 DBS 8.7 ROHS
Catalog Number
-
Brand Name
Aquamantys ®3
Version/Model Number
23-318-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 27, 2017
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
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
6c361c28-149c-4968-a7f9-d6e6b6e8560a
Public Version Date
March 12, 2019
Public Version Number
3
DI Record Publish Date
April 16, 2016
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |