Duns Number:628013963
Device Description: The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL Hemostati The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL Hemostatic Matrix.
Catalog Number
1502186
Brand Name
Floseal Special Applicator Tips
Version/Model Number
1502186
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
LMF
Product Code Name
Agent, Absorbable Hemostatic, Collagen Based
Public Device Record Key
4f63a72f-5529-439a-8c72-aaedea66ee11
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
May 14, 2015
Package DI Number
50085412091001
Quantity per Package
6
Contains DI Package
00085412091006
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |