Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
77246B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 12, 2022
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
OGJ
Product Code Name
Nerve block tray
Public Device Record Key
1b063d43-55e0-49c4-9258-9f45c5b65955
Public Version Date
October 13, 2022
Public Version Number
2
DI Record Publish Date
December 12, 2018
Package DI Number
20809160220938
Quantity per Package
20
Contains DI Package
10809160220931
Package Discontinue Date
October 12, 2022
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 | 548 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
| U | Unclassified | 1 |