Duns Number:618749857
Catalog Number
-
Brand Name
SCREW D.C. 1.5 x 25mm
Version/Model Number
17202
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K963433
Product Code
JDW
Product Code Name
Pin, Fixation, Threaded
Public Device Record Key
b8176e2e-47b2-4b9e-8146-6f81548a452d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 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 | 494 |
2 | A medical device with a moderate to high risk that requires special controls. | 2447 |