Duns Number:437222573
Device Description: ENDODRY one-click Storage and Drying System is an endoscope storage cabinet with directed ENDODRY one-click Storage and Drying System is an endoscope storage cabinet with directed airflow, which aids in drying, for storing flexible endoscopes which have been previously cleaned and high-level disinfected in a validated reprocessor. Pass thru Opening operator site left.
Catalog Number
15124
Brand Name
ENDODRY
Version/Model Number
Storage and Drying Cabinet
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
JRJ
Product Code Name
UNIT, DRYING
Public Device Record Key
cab8e576-dc14-4590-8e4e-a2a677f00ee4
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 2022
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 |