Duns Number:109903521
Device Description: TWNFX AB 6.5 STR ANCHR 2 38 DB STR
Catalog Number
7210210
Brand Name
TWINFIX / DURABRAID
Version/Model Number
7210210
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2020
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
MAI
Product Code Name
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Public Device Record Key
380be56c-545e-46b2-b641-f9cf4bca3bb3
Public Version Date
June 02, 2020
Public Version Number
5
DI Record Publish Date
April 12, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |