Duns Number:005083209
Device Description: Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressu Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation.
Catalog Number
1514243
Brand Name
COSEAL SPRAY SET
Version/Model Number
1514243
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
P030039,P030039,P030039
Product Code
NBE
Product Code Name
Sealant, polymerizing
Public Device Record Key
09639216-c653-41c6-9bc1-08c866ca0d72
Public Version Date
October 19, 2022
Public Version Number
3
DI Record Publish Date
September 30, 2020
Package DI Number
35413765583415
Quantity per Package
10
Contains DI Package
05413765583414
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |