Duns Number:534128491
Device Description: Screw Type Implant, 3.5 mm Diameter, 8 mm lengh
Catalog Number
I2-3.5,8
Brand Name
Titan Implant
Version/Model Number
I2-3.5,8
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
K132125,K132125
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
bdac1ac3-e246-4370-9a26-33fe57ce66fb
Public Version Date
May 13, 2019
Public Version Number
1
DI Record Publish Date
May 05, 2019
Package DI Number
17290107270011
Quantity per Package
10
Contains DI Package
07290107270014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 190 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 276 |