Duns Number:600030209
Device Description: Sterilizer,steam
Catalog Number
4472-2R
Brand Name
Model 4472
Version/Model Number
Model 4472
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
K032192
Product Code
FLE
Product Code Name
Sterilizer, Steam
Public Device Record Key
09156cb0-d95a-4047-b5ea-178defefcbc3
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 70 |