Duns Number:079402290
Device Description: Knotless Tissue Control Device, Violet Unidirectional (Antibacterial) Synthetic Absorbable Knotless Tissue Control Device, Violet Unidirectional (Antibacterial) Synthetic Absorbable Device
Catalog Number
SXPP1B432
Brand Name
STRATAFIX
Version/Model Number
SXPP1B432
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
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
a16872e3-950e-4e25-94b2-1137586e14ab
Public Version Date
April 25, 2022
Public Version Number
5
DI Record Publish Date
October 27, 2018
Package DI Number
30705031246533
Quantity per Package
12
Contains DI Package
10705031246539
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 |