Duns Number:106580145
Device Description: Stereotactic Tray
Catalog Number
PSS2881B
Brand Name
Aligned Medical Solutions
Version/Model Number
PSS2881B
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
250ac023-3d4c-442f-bd90-012b1abee79c
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
November 14, 2018
Package DI Number
B098PSS2881B1
Quantity per Package
8
Contains DI Package
B098PSS2881B0
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 |