Duns Number:078352849
Device Description: HC ITI 8.0mm Integrity - Delrin Healing Cap for Integrity 8.0mm Implant
Catalog Number
HC ITI 8.0mm Integrity
Brand Name
TatumSurgical/HC ITI 8.0mm Integrity-Delrin HC for Integrity 8.0mm Implant
Version/Model Number
Delrin Healing Cap for Integrity 8.0mm Implant
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 29, 2020
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
Yes
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
1cf3bc6c-3efe-4658-aa87-8d5049315bed
Public Version Date
June 01, 2020
Public Version Number
2
DI Record Publish Date
August 20, 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 |