Duns Number:005146311
Device Description: Fibrin Sealant Preparation and Application System for the preparation and application of T Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel Two-component Fibrin Sealant (2 mL Kit)
Catalog Number
1501250
Brand Name
Duploject Easy Prep
Version/Model Number
1501250
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
K020666,K020666
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
7adb8e1c-8d19-476e-812e-f769e54eba23
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50085412095832
Quantity per Package
6
Contains DI Package
00085412095837
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 |