Duns Number:131747628
Device Description: ANGEL cPRP PROCESSING SET US
Catalog Number
ABS-10063
Brand Name
Arthrex®
Version/Model Number
ABS-10063
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
-
Product Code
ORG
Product Code Name
Platelet and plasma separator for bone graft handling
Public Device Record Key
77865975-949a-4d05-90a1-c5980d08eb3b
Public Version Date
January 28, 2020
Public Version Number
3
DI Record Publish Date
February 15, 2017
Package DI Number
10888867084008
Quantity per Package
8
Contains DI Package
00888867084001
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 | 6506 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3411 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 2 |