Catalog Number
-
Brand Name
Regard
Version/Model Number
LD00427L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 26, 2021
Issuing Agency
In GS1
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHM
Product Code Name
Cesarean Section Tray
Public Device Record Key
012d913a-e803-4d60-b5d4-b036771e893a
Public Version Date
January 26, 2021
Public Version Number
3
DI Record Publish Date
December 09, 2020
Package DI Number
20194717108785
Quantity per Package
2
Contains DI Package
10194717108788
Package Discontinue Date
January 26, 2021
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 589 |
2 | A medical device with a moderate to high risk that requires special controls. | 961 |