Duns Number:131747628
Device Description: ARTHREX ACP DOUBLE SYRINGE SYSTEM
Catalog Number
ABS-10010S
Brand Name
Arthrex®
Version/Model Number
ABS-10010S
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
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
31657a5c-38d6-4bf5-bcad-ffc615c7c3dc
Public Version Date
July 23, 2020
Public Version Number
6
DI Record Publish Date
February 15, 2017
Package DI Number
10888867083797
Quantity per Package
5
Contains DI Package
00888867083790
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 |