Duns Number:557223252
Device Description: HemosIL RecombiPlasTin 2G (20 mL)
Catalog Number
00020003050
Brand Name
HemosIL RecombiPlasTin 2G (20 mL)
Version/Model Number
00020003050
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
K070005
Product Code
GJS
Product Code Name
TEST, TIME, PROTHROMBIN
Public Device Record Key
0a186ddc-da5f-4261-90e4-16cca6261020
Public Version Date
July 13, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 272 |