Duns Number:088480717
Device Description: ATOMO Disposable Impression Trays, Quadrant Upper Left / Lower Right
Catalog Number
-
Brand Name
ATOMO
Version/Model Number
AA0807
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHY
Product Code Name
Tray, Impression, Preformed
Public Device Record Key
74903622-a065-41c0-baa6-d112e645b568
Public Version Date
September 15, 2022
Public Version Number
1
DI Record Publish Date
September 07, 2022
Package DI Number
D883AA08073
Quantity per Package
30
Contains DI Package
D883AA08071
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |