Duns Number:600030209
Device Description: Sterilizer,steam
Catalog Number
66120-2V-USA
Brand Name
Model 66120-2V
Version/Model Number
Model 66120-2V
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
K181456
Product Code
FLE
Product Code Name
Sterilizer, Steam
Public Device Record Key
83244e2c-fea3-4b8e-aad1-8ad2df8efa35
Public Version Date
January 13, 2020
Public Version Number
1
DI Record Publish Date
January 05, 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 |