Duns Number:106580145
Device Description: Vein Pack - RX
Catalog Number
AMS4050
Brand Name
Aligned Medical Solutions
Version/Model Number
AMS4050
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
LRO
Product Code Name
General surgery tray
Public Device Record Key
4781cb5e-f13f-456f-aa11-9600d20f5cc4
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
November 01, 2018
Package DI Number
B098AMS40501
Quantity per Package
10
Contains DI Package
B098AMS40500
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 |