Duns Number:801679200
Device Description: Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-20 Procedure Pack
Catalog Number
-
Brand Name
HARVEST®
Version/Model Number
51402
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
BK120038,BK120038
Product Code
ORG
Product Code Name
Platelet and plasma separator for bone graft handling
Public Device Record Key
3a85336c-93a7-490d-a991-859e9bf930c1
Public Version Date
September 02, 2022
Public Version Number
7
DI Record Publish Date
September 15, 2016
Package DI Number
35020583514028
Quantity per Package
6
Contains DI Package
05020583514027
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |