Duns Number:432066322
Device Description: M6 Handle with Flange
Catalog Number
9CC0.13.03D
Brand Name
ProMade
Version/Model Number
9CC0.13.03D
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
K112158
Product Code
JDI
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Public Device Record Key
8254e5c9-e23a-4009-a8ae-539b5d2beccd
Public Version Date
September 29, 2022
Public Version Number
1
DI Record Publish Date
September 21, 2022
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 |