Duns Number:830016148
Device Description: Unitek™ TAD Introductory Kit. Implants in the kit are provided sterile by irradiation and Unitek™ TAD Introductory Kit. Implants in the kit are provided sterile by irradiation and have clinically relevant sizes. The instruments in the kit need to be moist heat/steam sterilized before use.
Catalog Number
504-101
Brand Name
3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit
Version/Model Number
504-101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
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
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
8e332b5a-0049-4dea-988d-184452f95a12
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 23, 2015
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |