Duns Number:318034329
Device Description: Tacs are used for the fixation of membranes (resorbable membranes nonresorbable membranes) Tacs are used for the fixation of membranes (resorbable membranes nonresorbable membranes) to the bone structure.Tacs are intended for single use only.The Tacs consist of titanium alloy Grade 5 and are delivered non sterile.
Catalog Number
MTAB0
Brand Name
Tac, dental
Version/Model Number
MTAB0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
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
K130682,K130682
Product Code
DZL
Product Code Name
Screw, Fixation, Intraosseous
Public Device Record Key
598fa8a9-5fe1-4f01-ad75-8b9169820964
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 13, 2015
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 | 4140 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 237 |