Duns Number:078352849
Device Description: Tatum Socket Guide 6.0mm (actual size 5.8mm undersized to fit osteotomy for 6.0mm Implant) Tatum Socket Guide 6.0mm (actual size 5.8mm undersized to fit osteotomy for 6.0mm Implant) to check osteotomies are parallel.
Catalog Number
SG.58T
Brand Name
Tatum Socket Guide 6.0mm
Version/Model Number
Socket Guide 6.0mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 26, 2020
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
FZX
Product Code Name
Guide, Surgical, Instrument
Public Device Record Key
fc5b0967-8068-4b53-ba83-a62853cab56d
Public Version Date
June 29, 2020
Public Version Number
2
DI Record Publish Date
April 14, 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 |