Duns Number:600030209
Device Description: Sterilizer,steam
Catalog Number
AMS10-120-T
Brand Name
T-Edge 10
Version/Model Number
T-Edge 10
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
K143311,K213080
Product Code
FLE
Product Code Name
Sterilizer, Steam
Public Device Record Key
38e7d5ec-3768-4951-81aa-2af547500a67
Public Version Date
January 10, 2022
Public Version Number
2
DI Record Publish Date
November 16, 2020
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 |