Duns Number:042763706
Device Description: ACE ORTHO BONE SCREW 1.8X6MM CUFF STERILE TI 5/PKG TI (6AL4V ELI)
Catalog Number
45491714
Brand Name
TRUFIX Bone Fixation System
Version/Model Number
45491714
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
K061397,K061397
Product Code
OAT
Product Code Name
Implant, endosseous, orthodontic
Public Device Record Key
6df80cf2-3ca1-4065-b9ce-f86064569075
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2015
Package DI Number
10614950006561
Quantity per Package
5
Contains DI Package
00614950006564
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvec Bag
| 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 |