Duns Number:628013963
Device Description: The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant C The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components.
Catalog Number
934033
Brand Name
Coseal Surgical Sealant Replacement Applicator
Version/Model Number
934033
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
88949064-0dcd-4932-a0db-18094932908e
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
October 09, 2017
Package DI Number
50085412083327
Quantity per Package
5
Contains DI Package
00085412083322
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |