Duns Number:628013963
Device Description: Floseal with Recothrom - 5mL
Catalog Number
ADS202105
Brand Name
FLOSEAL HEMOSTATIC MATRIX
Version/Model Number
ADS202105
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P990009,P990009,P990009
Product Code
PMX
Product Code Name
Absorbable collagen hemostatic agent with thrombin
Public Device Record Key
50b034e0-7d03-4db3-ac09-5673887ca475
Public Version Date
April 26, 2022
Public Version Number
1
DI Record Publish Date
April 18, 2022
Package DI Number
50085412827952
Quantity per Package
6
Contains DI Package
00085412827957
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 |