Duns Number:131747628
Device Description: DX Swivelock, 3.5 x 13.5 mm
Catalog Number
AR-8979P
Brand Name
Arthrex®
Version/Model Number
AR-8979P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
MBI
Product Code Name
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Public Device Record Key
1a46f54c-fed3-4486-9816-c7eab804ca3f
Public Version Date
March 02, 2022
Public Version Number
27
DI Record Publish Date
February 15, 2017
Package DI Number
10888867202907
Quantity per Package
5
Contains DI Package
00888867202900
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 |