Duns Number:076649467
Device Description: A sterile, single use, syringe assembly that is intended for separating and concentrating A sterile, single use, syringe assembly that is intended for separating and concentrating blood components along with the use of a desktop centrifuge. It enables blood to be separated and aspirated in a single device after they have been centrifuged.
Catalog Number
-
Brand Name
Adaptive
Version/Model Number
GAAPS-25
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
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
BK200449,BK200449
Product Code
ORG
Product Code Name
Platelet And Plasma Separator For Bone Graft Handling
Public Device Record Key
0d1da47a-e03f-4570-b29f-13f2177b55cf
Public Version Date
February 17, 2022
Public Version Number
1
DI Record Publish Date
February 09, 2022
Package DI Number
00850034511900
Quantity per Package
1
Contains DI Package
00850034511269
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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. | 17 |