Duns Number:080448429
Device Description: BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .3125
Catalog Number
128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.31
Brand Name
EZ-TRAX™
Version/Model Number
128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.31
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
6fe8e0ce-24a6-4b02-91ae-0e72d91d21cb
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
May 17, 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 |