Duns Number:113170088
Device Description: The Etchmaster CO2 cartridges are intended to be used in conjunction with the Etchmaster C The Etchmaster CO2 cartridges are intended to be used in conjunction with the Etchmaster Cordless Handpiece as the air source.
Catalog Number
EMCO2
Brand Name
Etchmaster
Version/Model Number
EMCO2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2018
Issuing Agency
In HIBCC
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030292
Product Code
KOJ
Product Code Name
Airbrush
Public Device Record Key
a11ade8b-81b4-474f-8660-99546712a070
Public Version Date
August 31, 2018
Public Version Number
5
DI Record Publish Date
September 09, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |