Duns Number:079402290
Device Description: Violet Antibacterial Polydioxanone, Knotless Tissue Control Device
Catalog Number
SXPP1A416
Brand Name
STRATAFIX
Version/Model Number
SXPP1A416
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
-
Product Code
NEW
Product Code Name
SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
Public Device Record Key
474896d9-e9af-4226-87fd-f70347cf9c12
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
January 26, 2018
Package DI Number
30705031245376
Quantity per Package
12
Contains DI Package
10705031245372
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |