Duns Number:175254820
Catalog Number
-
Brand Name
Custom Healthcare Systems, Inc.
Version/Model Number
B9-19811
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KXG
Product Code Name
Applicator, Absorbent Tipped, Sterile
Public Device Record Key
41263c87-fb7e-47d4-8b7f-51819952b66f
Public Version Date
July 15, 2020
Public Version Number
1
DI Record Publish Date
July 07, 2020
Package DI Number
20811870035085
Quantity per Package
40
Contains DI Package
00811870035081
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 |