Duns Number:131747628
Device Description: 6" X 11.5" HELIX COMPOSITE LAYER
Catalog Number
ABS-4050
Brand Name
Arthrex®
Version/Model Number
ABS-4050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
FDA Premarket Submission
K130350,K130350
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
510cbad9-1ba5-4767-94d3-ed3a21f92e0b
Public Version Date
June 19, 2020
Public Version Number
8
DI Record Publish Date
February 15, 2017
Package DI Number
10888867225326
Quantity per Package
5
Contains DI Package
00888867225329
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 |