Duns Number:044668515
Device Description: SUPPLIES ATMOS TMP THERMOFORMING MATERIAL .015 5 IN SQ 75/PK
Catalog Number
909-036816
Brand Name
Atmos
Version/Model Number
909-036816
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
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
-
Product Code
KMY
Product Code Name
POSITIONER, TOOTH, PREFORMED
Public Device Record Key
32489dd4-3a49-4886-8a44-63c4054f67df
Public Version Date
August 19, 2022
Public Version Number
1
DI Record Publish Date
August 11, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 16634 |
2 | A medical device with a moderate to high risk that requires special controls. | 982 |