Duns Number:938647021
Device Description: SynchroSeal
Catalog Number
-
Brand Name
da Vinci Energy
Version/Model Number
480440
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
NAY
Product Code Name
System, surgical, computer controlled instrument
Public Device Record Key
c2647602-32e9-403a-bc7a-d906f78b4521
Public Version Date
November 23, 2021
Public Version Number
3
DI Record Publish Date
December 10, 2019
Package DI Number
10886874117306
Quantity per Package
6
Contains DI Package
00886874117309
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 376 |