Duns Number:080448429
Device Description: Bracket Insert Frame Assembly AL Size (H) 2.4" (W) 1.550"
Catalog Number
125 BRACKETINSERTFRAMEASSY-AL-2.4.-1.550
Brand Name
EZ-TRAX™
Version/Model Number
125 BRACKETINSERTFRAMEASSY-AL-2.4.-1.550
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
8c583ef5-e313-408a-8b75-e175f04cdc00
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
February 16, 2021
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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 91 |