Duns Number:428717469
Device Description: This device drying cabinet dries and stores flexible endoscopes keeping them in aseptic co This device drying cabinet dries and stores flexible endoscopes keeping them in aseptic conditions while waiting for the next patient.
Catalog Number
ED 100/2
Brand Name
Steelco
Version/Model Number
ED 100/2
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
8b1b79f0-5954-4f52-a374-2d4ed20189f4
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 17, 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 | 44 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 83 |