Duns Number:106580145
Device Description: Dr Fred Chiu Single Shot Epi Tray - Rx
Catalog Number
AMS1095E
Brand Name
Aligned Medical Solutions
Version/Model Number
AMS1095E
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
OGE
Product Code Name
Epidural anesthesia kit
Public Device Record Key
04c6f527-6899-4c85-a716-34c0ff669afe
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
April 08, 2019
Package DI Number
B098AMS1095E1
Quantity per Package
15
Contains DI Package
B098AMS1095E0
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 |