Duns Number:197201572
Device Description: Box containing 1000 Kova ONO Petters (plastic disposable pipette for urinalysis)
Catalog Number
4249
Brand Name
Kova Plastics
Version/Model Number
4249
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
JQW
Product Code Name
Station, Pipetting And Diluting, For Clinical Use
Public Device Record Key
c1f791ec-3ceb-4905-8b1c-4673e346c71f
Public Version Date
August 06, 2021
Public Version Number
1
DI Record Publish Date
July 29, 2021
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |