Duns Number:860396609
Device Description: Acura Stabilization System - Rod Template
Catalog Number
F004.0006
Brand Name
Rod Template
Version/Model Number
F004.0006
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWT
Product Code Name
Template
Public Device Record Key
26cccdfc-ed49-4380-8fd9-84183e08c7a9
Public Version Date
March 25, 2022
Public Version Number
1
DI Record Publish Date
March 17, 2022
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 | 55 |
2 | A medical device with a moderate to high risk that requires special controls. | 124 |