Duns Number:078413594
Device Description: Personal Use Kit OC-Light S for St. Joseph Mrcy Oklnd
Catalog Number
-
Brand Name
OC-Light S
Version/Model Number
FBPUS-MCY
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
K143325
Product Code
KHE
Product Code Name
Reagent, Occult Blood
Public Device Record Key
b94be561-984e-4d14-91a8-22ebd72411eb
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 615 |