Duns Number:144723868
Device Description: ORTHOGNATHIC, FINAL SPLINT
Catalog Number
MC-K002
Brand Name
AccuPlan System
Version/Model Number
MC-K002
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
DZJ
Product Code Name
Driver, Wire, And Bone Drill, Manual
Public Device Record Key
544587c8-2ae7-4a10-8d54-ab4390df7c66
Public Version Date
February 21, 2022
Public Version Number
3
DI Record Publish Date
July 30, 2021
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. | 103 |