Duns Number:813116209
Device Description: The Rack and Two Shelves 24-inch x 36-inch x 48-inch (Double Door) is designed for use wit The Rack and Two Shelves 24-inch x 36-inch x 48-inch (Double Door) is designed for use with the sterilization systems.
Catalog Number
AX014112
Brand Name
NA
Version/Model Number
AX014112
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLE
Product Code Name
Sterilizer, steam
Public Device Record Key
637fae8a-eb06-46d8-aaea-31fcb0e3e530
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
September 14, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 548 |