Duns Number:002092976
Device Description: OPTIMAL MAXX .022 BOND SGL NON TAPER NON CONVERT BUC TUBE UR LL 6 -10T 0DO PK10
Catalog Number
D-800XX2-231B
Brand Name
Phoenix Optimal Maxx
Version/Model Number
D-800XX2-231B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
DZD
Product Code Name
TUBE, ORTHODONTIC
Public Device Record Key
a92349bb-e6fa-4da7-8118-89d97bf00c36
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 2020
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 | 782 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |