Duns Number:963856096
Device Description: Uniplanar Screw, SS, 8.50mm x 25mm
Catalog Number
25-14-8525
Brand Name
Stainless Steel
Version/Model Number
25-14-8525
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 15, 2015
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
KWP
Product Code Name
Appliance, Fixation, Spinal Interlaminal
Public Device Record Key
0a8e6342-75d0-4e3b-b592-9556fe0bbe0d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2014
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 | 1079 |
2 | A medical device with a moderate to high risk that requires special controls. | 2066 |