Duns Number:078352849
Device Description: Tapered Tap 8.0mm diameter x 11mm length, Non-IrrigatedA metal surgical instrument designe Tapered Tap 8.0mm diameter x 11mm length, Non-IrrigatedA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of Dental Implants. It is made of high-grade stainless steel,can be used in a dental hand piece or manually with a ratchet
Catalog Number
TTAP 8.0x11
Brand Name
Brasseler
Version/Model Number
TTAP 8.0x11
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
HWX
Product Code Name
Tap, Bone
Public Device Record Key
da4747dc-c8cd-4fbf-bbd2-fdb1a5298caa
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 29, 2021
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 |