Duns Number:197201572
Device Description: Box containing 100 Kova Slide IIs without grids (plastic 4-chambered microscope slide with Box containing 100 Kova Slide IIs without grids (plastic 4-chambered microscope slide without gridlines for urinalysis)
Catalog Number
87118 / 87118E
Brand Name
Kova Plastics
Version/Model Number
KOVASLIDEII
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
KEW
Product Code Name
Slides, Microscope
Public Device Record Key
fd9b617b-5cad-4249-8063-1e785e49aed5
Public Version Date
May 13, 2022
Public Version Number
2
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 |