Duns Number:432066322
Device Description: Double offset Broach handle RIGHT M2 Connection
Catalog Number
9095.11.007
Brand Name
Double offset Broach handle
Version/Model Number
Broach Handle
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
-
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
K140975
Product Code
JDI
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Public Device Record Key
14639220-2dcd-4ba9-aadc-6cb9a0b20a76
Public Version Date
August 09, 2018
Public Version Number
4
DI Record Publish Date
August 05, 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 | 595 |
2 | A medical device with a moderate to high risk that requires special controls. | 3634 |