Duns Number:175254820
Catalog Number
-
Brand Name
Custom Healthcare Systems, Inc.
Version/Model Number
CUS1365-02
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"
-
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
e85396f8-8b42-400e-9afd-b5416aa5f3bb
Public Version Date
August 05, 2020
Public Version Number
1
DI Record Publish Date
July 28, 2020
Package DI Number
20811870035160
Quantity per Package
10
Contains DI Package
00811870035166
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
NA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 210 |
2 | A medical device with a moderate to high risk that requires special controls. | 304 |