Duns Number:092364462
Catalog Number
-
Brand Name
MAI
Version/Model Number
81574
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
-
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
a92d42a8-2e28-416c-9341-7f94a4bbb4b3
Public Version Date
November 18, 2020
Public Version Number
1
DI Record Publish Date
November 10, 2020
Package DI Number
20809160295400
Quantity per Package
20
Contains DI Package
10809160295403
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 |