Duns Number:078352849
Device Description: Hand Tool #14 Driver for 3.0mm and 3.5mm one piece ball post Implant (SB) and 3.5-4.0mm tw Hand Tool #14 Driver for 3.0mm and 3.5mm one piece ball post Implant (SB) and 3.5-4.0mm two-piece small ball abutment.
Catalog Number
HT.14
Brand Name
Tatum Surgical/Hand Tool
Version/Model Number
Hand Tool / HT.14
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
-
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
NDP
Product Code Name
Accessories, implant, dental, endosseous
Public Device Record Key
b6a07eaf-92cb-48cd-8bf6-56742bfc6850
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
April 15, 2018
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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |