Duns Number:631085206
Catalog Number
UF(II) 5505SF
Brand Name
UF(II) Fixture
Version/Model Number
UF(II) 5505SF
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170608
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
bd940723-97f3-45dd-a4b2-f6bfeb50b813
Public Version Date
April 07, 2022
Public Version Number
1
DI Record Publish Date
March 30, 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 | 101 |
2 | A medical device with a moderate to high risk that requires special controls. | 3540 |