Duns Number:131747628
Device Description: 3.0" DIAMETER HELIX COMPOSITE LAYER
Catalog Number
ABS-4055
Brand Name
Arthrex®
Version/Model Number
ABS-4055
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)
-
FDA Premarket Submission
K130350,K130350
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
31c128c8-395c-48d4-8178-c7c4e0d2cd56
Public Version Date
June 19, 2020
Public Version Number
7
DI Record Publish Date
February 15, 2017
Package DI Number
10888867225371
Quantity per Package
10
Contains DI Package
00888867225374
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 |