Duns Number:600030209
Device Description: Sterilizer,steam
Catalog Number
TTA2540-1R15M
Brand Name
2540M
Version/Model Number
2540M
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
K833837
Product Code
FLE
Product Code Name
Sterilizer, Steam
Public Device Record Key
79e4735c-1303-46a9-a4ea-56db9f1b44c3
Public Version Date
October 17, 2018
Public Version Number
1
DI Record Publish Date
September 16, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 70 |