Duns Number:131107757
Device Description: Centrifuge for preparation of platelet rich plasma
Catalog Number
278010
Brand Name
PEAK® Platelet Rich Plasma System
Version/Model Number
64002-01
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
-
Product Code
ORG
Product Code Name
Platelet And Plasma Separator For Bone Graft Handling
Public Device Record Key
84924fad-f514-4e49-8c5a-53398afb5e15
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
August 17, 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |
| U | Unclassified | 5 |