Duns Number:300238441
Device Description: Surgical Handpiece without accessories
Catalog Number
-
Brand Name
Screwdriver angled 90° WS-90
Version/Model Number
30014006
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
-
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
KMW
Product Code Name
Handpiece, Rotary Bone Cutting
Public Device Record Key
5caf4e7e-7884-4760-8ca9-851fc2121eec
Public Version Date
August 09, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 | 343 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |