Duns Number:078352849
Device Description: Tatum One-Piece Implant Kit Box - #04-4870 - Autoclavable Box to hold all Drills, Drivers Tatum One-Piece Implant Kit Box - #04-4870 - Autoclavable Box to hold all Drills, Drivers and ratchet for One-Piece Implant placement
Catalog Number
Tatum One-Piece Implant Kit Box
Brand Name
Tatum One-Piece Implant Kit Box
Version/Model Number
Tatum One-Piece Implant Kit Box
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
eea6e7a7-4be4-420e-a7da-bf94e98a7255
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
December 07, 2020
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 |