Duns Number:429341410
Device Description: Table top steam sterilizer to be used in medical and dental practices, hospitals, clinics, Table top steam sterilizer to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
Catalog Number
M7A720010
Brand Name
mocom
Version/Model Number
B Classic-17
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
K161848
Product Code
FLE
Product Code Name
Sterilizer, Steam
Public Device Record Key
85afdf0d-1e24-4a0c-9d9d-bec7caae490c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 31, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |