Duns Number:277657631
Device Description: HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mechanical act HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mechanical action.Box with 2 x 2g multiple use syringes of HEMOSTASYL paste
Catalog Number
246050
Brand Name
ACTEON
Version/Model Number
Hemostasyl syringes
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
-
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
K082116,K082116
Product Code
MVL
Product Code Name
Cord, Retraction
Public Device Record Key
55f1bf63-eccd-4c5b-89eb-84edcf5bf970
Public Version Date
March 12, 2020
Public Version Number
1
DI Record Publish Date
March 04, 2020
Package DI Number
03760243007125
Quantity per Package
2
Contains DI Package
03760243000935
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 7 |