Duns Number:131747628
Device Description: Self-Punching Triple Loaded FiberTak
Catalog Number
AR-3633SP
Brand Name
Arthrex®
Version/Model Number
AR-3633SP
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
06525883-e9ba-4cd1-a3ab-04443726825c
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 30, 2021
Package DI Number
10888867369969
Quantity per Package
5
Contains DI Package
00888867369962
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 |