Duns Number:131747628
Device Description: FIBERWIRE, #5, WHITE, 38"
Catalog Number
AR-7215
Brand Name
Arthrex®
Version/Model Number
AR-7215
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
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
3b47dda1-0b7b-40f1-8149-c0dd84e00269
Public Version Date
July 28, 2021
Public Version Number
9
DI Record Publish Date
December 07, 2017
Package DI Number
10888867207933
Quantity per Package
12
Contains DI Package
00888867207936
Package Discontinue Date
July 27, 2021
Package Status
Not 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 |