Duns Number:204137145
Device Description: Automated instrument washer. Shorter height than the original HYDRIM L110W-D01-G4 model.
Catalog Number
L110W-D01SH-G4
Brand Name
HYDRIM L110W G4 Instrument Washer
Version/Model Number
L110W-D01SH-G4
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
272ddbcb-0ac3-4342-9f7a-de89fe8ad034
Public Version Date
October 08, 2018
Public Version Number
1
DI Record Publish Date
September 07, 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 |