Duns Number:008256356
Device Description: APC™ Flash-Free Victory Series Low Profile™ MBT™ Appliance System U/L 6x7 022 1 Case Kit C APC™ Flash-Free Victory Series Low Profile™ MBT™ Appliance System U/L 6x7 022 1 Case Kit CHk
Catalog Number
4024-131
Brand Name
3M™
Version/Model Number
4024-131
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
DYH
Product Code Name
ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
Public Device Record Key
3bf32243-d924-4c7c-8720-a85085398c08
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 25, 2017
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 610 |