Duns Number:078352849
Device Description: Tatum EZ Screw Driver, 2.5mm Hex for bone screws
Catalog Number
EZSD
Brand Name
Tatum Surgical-EZ Screw Driver
Version/Model Number
EZSD
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 10, 2021
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
ffaebcbb-5dd6-4506-b1a4-8f35379c0338
Public Version Date
February 11, 2021
Public Version Number
4
DI Record Publish Date
May 24, 2019
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 |