Duns Number:868856969
Catalog Number
11-001320
Brand Name
UMA Insert-IMZ 3.3-2.0mm
Version/Model Number
11-001320
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
K863680
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
130f33bd-7668-401d-b0c4-ef4be6eaee46
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
August 31, 2016
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 | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 1817 |
U | Unclassified | 6 |