Duns Number:092364462
Catalog Number
-
Brand Name
ACCUTRAY
Version/Model Number
5200114
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 25, 2019
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
928e7e88-daf4-437f-ac21-6b2683f74ee3
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
November 07, 2016
Package DI Number
20809160113490
Quantity per Package
24
Contains DI Package
10809160113493
Package Discontinue Date
March 25, 2019
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 |