Duns Number:175254820
Catalog Number
-
Brand Name
Custom Healthcare Systems Inc.
Version/Model Number
JPK-19757
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
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
18346b0b-938d-45c2-8437-61afeb14a879
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
March 09, 2020
Package DI Number
20811870034576
Quantity per Package
1
Contains DI Package
00811870034572
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 |