Duns Number:266048588
Device Description: GOUTP for 2 archs
Catalog Number
GOUTP
Brand Name
Smilers
Version/Model Number
Attachement placement aligner
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212961,K212961
Product Code
NXC
Product Code Name
Aligner, Sequential
Public Device Record Key
e5fbe24f-da2c-4e91-bbf6-9cb552dbea0f
Public Version Date
April 28, 2022
Public Version Number
1
DI Record Publish Date
April 20, 2022
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. | 9 |