Duns Number:687941818
Device Description: Wire Pin Screw, 2mm Shaft Diameter x 1.6mm Thread Diameter x 100mm Total Length x 15mm Thr Wire Pin Screw, 2mm Shaft Diameter x 1.6mm Thread Diameter x 100mm Total Length x 15mm Thread Length
Catalog Number
-
Brand Name
PIN SCREW
Version/Model Number
31916-15-10
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
K061599
Product Code
JDW
Product Code Name
Pin, Fixation, Threaded
Public Device Record Key
a9533695-372b-4961-be64-1e762b951cff
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4455 |