Duns Number:131747628
Device Description: TRIMANO Fortis Knee Kit
Catalog Number
1002.34A0
Brand Name
Arthrex®
Version/Model Number
1002.34A0
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWN
Product Code Name
TABLE AND ATTACHMENTS, OPERATING-ROOM
Public Device Record Key
91fc1bad-419c-44d4-8d86-3f215876e16c
Public Version Date
June 28, 2021
Public Version Number
2
DI Record Publish Date
March 12, 2019
Package DI Number
10888867299563
Quantity per Package
6
Contains DI Package
00888867299566
Package Discontinue Date
June 26, 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 |