Duns Number:204137145
Device Description: Automated instrument washer (Loaner)
Catalog Number
C51W-D01-L
Brand Name
HYDRIM C51W Instrument Washer
Version/Model Number
C51W-D01-L
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
-
Product Code
LDS
Product Code Name
Device, Pasteurization, Hot Water
Public Device Record Key
8d15eb9e-a9a8-4118-b6c0-28e0d626cd6e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 17, 2018
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. | 114 |