Duns Number:783546109
Device Description: PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes form
Catalog Number
9007
Brand Name
PreveLeak™ Surgical Sealant
Version/Model Number
2.5 ml
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
NBE
Product Code Name
Sealant,Polymerizing
Public Device Record Key
af05c079-1976-4fe2-ab4d-25dcee854cbc
Public Version Date
February 21, 2022
Public Version Number
3
DI Record Publish Date
December 31, 2015
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 |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 4 |