Duns Number:005146311
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
0600021
Brand Name
Coseal Spray Set
Version/Model Number
0600021
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
9e0d8eba-a38f-4d0b-80c9-244bdf25c4c3
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
March 23, 2017
Package DI Number
50085412087783
Quantity per Package
10
Contains DI Package
00085412087788
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |