Duns Number:042763706
Device Description: SELF DRILL BONE SCREWS 5/PKG 1.25MM SPLINE 4HD 2.7TD 15TL TI
Catalog Number
45423005
Brand Name
TRUFIX Bone Fixation System
Version/Model Number
45423005
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
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
K951392,K951392
Product Code
OAT
Product Code Name
Implant, endosseous, orthodontic
Public Device Record Key
396207d7-60c8-4ae3-bf67-b62fc51cba9b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 28, 2017
Package DI Number
10614950005939
Quantity per Package
5
Contains DI Package
00614950005932
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Plastic cassette
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |