Duns Number:082930884
Device Description: WIN 10 CUP UPGRADE FOR GSL (IN WARRANTY)
Catalog Number
-
Brand Name
WIN10 CPU UPGRADE FOR GSL(IN WARRANTY)
Version/Model Number
23GSLWARW10CPU
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042542
Product Code
JOY
Product Code Name
DEVICE, AUTOMATED CELL-LOCATING
Public Device Record Key
9c615488-18e5-449c-bef4-a76c18357870
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
November 09, 2019
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 206 |