Duns Number:557223252
Device Description: HemosIL Rinse Solution (ACL Futura Advance) 2 LIT
Catalog Number
00020009320
Brand Name
HemosIL Rinse Solution (ACL Futura Advance)
Version/Model Number
00020009320
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JPA
Product Code Name
SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
Public Device Record Key
880a729c-2f39-4e62-a18c-4b3738328b9d
Public Version Date
July 09, 2021
Public Version Number
3
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 |