Duns Number:429341410
Device Description: Tethys H10 is intended only for the washing and/or thermal disinfection of re-usable surgi
Catalog Number
M7E200310
Brand Name
mocom
Version/Model Number
Tethys H10
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
-
Product Code
MDZ
Product Code Name
Cleaners, Medical Devices
Public Device Record Key
7e41df0c-1920-4d84-a681-944f689cf3eb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 01, 2016
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 |