Duns Number:078352849
Device Description: Tatum Integrity Implant kit: A kit designed for simplicity and ease of use in placing Tatu Tatum Integrity Implant kit: A kit designed for simplicity and ease of use in placing Tatum Integrity Implants: Kit Includes:DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.5x11, 14, 17, 20, DR4.0x11, 14, 17, 20, DR4.5x11,14,17, 20, DR5.0x11, 14, 17, 20, DR6.0x11,14,17,20. DR7.0x11, 14,17. DR8.0x11, 14, 17. HT.02, 03, 03L, 06, 06L, 07, 07L, 08, 09, 09L, 26, 27, 29, & 30. Tatum Ratchet, set of 4 paralleling pins. Autoclaveable Cassette/Container for all pieces
Catalog Number
ASY ITI Kit Master
Brand Name
Tatum Integrity Implant Kit
Version/Model Number
Master Integrity Implant Kit 3.7-8.0
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
e70a79bc-f49f-4524-8daf-db0d29f74503
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 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 |