Duns Number:113344790
Device Description: SALVIN FIXATION SCREW 2.0MMX13MM LENGTH
Catalog Number
-
Brand Name
FIX-2.0X13-PT
Version/Model Number
Rev4
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073342
Product Code
DZL
Product Code Name
Screw, Fixation, Intraosseous
Public Device Record Key
713165cd-a5de-4de8-be43-93e38813d7ad
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 30, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |
| 3 | A medical device with high risk that requires premarket approval | 3 |