Duns Number:131747628
Device Description: BioSurge I with 2.5cc AlloSync Pure
Catalog Number
ABS-2016-01
Brand Name
Arthrex®
Version/Model Number
ABS-2016-01
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
-
Product Code
ORG
Product Code Name
Platelet and plasma separator for bone graft handling
Public Device Record Key
b381f32f-c8b9-419c-a3b1-64a95cab8e9b
Public Version Date
September 21, 2021
Public Version Number
5
DI Record Publish Date
May 20, 2019
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 | 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 |