Duns Number:159009294
Device Description: Tip Assy, Male, Torx, Reverse Captive, T20
Catalog Number
-
Brand Name
Shukla Xtract-All Spine MKS1031 (Legacy)
Version/Model Number
MBT142
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HXX
Product Code Name
Screwdriver
Public Device Record Key
730556cb-9fed-4faa-8edc-f7e4f8c3d4c2
Public Version Date
July 30, 2021
Public Version Number
1
DI Record Publish Date
July 22, 2021
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 | 706 |