Duns Number:092364462
Device Description: Kit: Single Shot Epidural 20/Cs
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
59553
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
f31b3da2-4cab-41ff-b458-1026c561034a
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
20809160010515
Quantity per Package
20
Contains DI Package
10809160010518
Package Discontinue Date
-
Package Status
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 | 548 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
| U | Unclassified | 1 |