Duns Number:106580145
Device Description: Transforaminal Tray - RX
Catalog Number
0090645
Brand Name
Aligned Medical Solutions
Version/Model Number
0090645
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
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
OFT
Product Code Name
Spinal epidural anesthesia kit
Public Device Record Key
c79238ec-060a-4a1c-8bba-1f6aa3bfe8ef
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
October 31, 2018
Package DI Number
B09800906451
Quantity per Package
20
Contains DI Package
B09800906450
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 578 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1711 |