Duns Number:592616445
Device Description: Tray/case used to hold Enztec X-Wing and associated medical devices used in ligament recon Tray/case used to hold Enztec X-Wing and associated medical devices used in ligament reconstruction procedures
Catalog Number
72205275
Brand Name
X-Wing Tray
Version/Model Number
72205275
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
eb652207-5aab-4ce9-9770-28457f11b41e
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
December 02, 2020
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 | 107 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |