Duns Number:434263590
Device Description: Slide Prep Evo™
Catalog Number
W086-40N
Brand Name
Slide Prep Evo™
Version/Model Number
W086-40N
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
-
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
JTC
Product Code Name
Device, Microtiter Diluting/Dispensing
Public Device Record Key
c03ab98a-9a5a-4b93-899e-e59cdb254f00
Public Version Date
May 05, 2021
Public Version Number
1
DI Record Publish Date
April 27, 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 | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |