Duns Number:140727624
Device Description: Adult Myelography Tray
Catalog Number
A4324AWSP
Brand Name
Adult Myelography Tray
Version/Model Number
A4324AWSP
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
0e0c86ed-0f78-42ba-8f38-ec30566e26c3
Public Version Date
June 22, 2021
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
20886333220643
Quantity per Package
10
Contains DI Package
00886333220649
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |