Duns Number:079402290
Device Description: Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Device
Catalog Number
SXMP1B101
Brand Name
STRATAFIX
Version/Model Number
SXMP1B101
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
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
e5976b7a-7b73-42a8-8950-82b141e21e63
Public Version Date
February 21, 2022
Public Version Number
6
DI Record Publish Date
February 21, 2018
Package DI Number
30705031236770
Quantity per Package
12
Contains DI Package
10705031236776
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 |