Duns Number:117472302
Device Description: Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgi Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses.
Catalog Number
ADS201810
Brand Name
PREVELEAK SURGICAL SEALANT
Version/Model Number
ADS201810
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"
Yes
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
P100030,P100030
Product Code
NBE
Product Code Name
Sealant, polymerizing
Public Device Record Key
c3c13b6b-76ad-4131-b9e3-3658daf0fa1f
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
June 01, 2021
Package DI Number
25413765583609
Quantity per Package
1
Contains DI Package
05413765583605
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 3 |