Duns Number:201179681
Catalog Number
-
Brand Name
EPOC BGEM CREA TEST CARD, VET, HESKA
Version/Model Number
CT-1007-US-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 02, 2020
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
-
Product Code Name
-
Public Device Record Key
d5df4fbc-d3e2-4b57-a54b-d4f8780308c2
Public Version Date
December 02, 2020
Public Version Number
3
DI Record Publish Date
August 17, 2016
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |