Duns Number:344261631
Device Description: ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent tra ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent transfer in syringes for clinical application.
Catalog Number
02-0602
Brand Name
ManuMix
Version/Model Number
02-0601
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JDZ
Product Code Name
Mixer, Cement, For Clinical Use
Public Device Record Key
dfad0214-b60b-48f6-b9d4-481fda4602bf
Public Version Date
October 20, 2021
Public Version Number
1
DI Record Publish Date
October 12, 2021
Package DI Number
04260056881572
Quantity per Package
10
Contains DI Package
04260056881565
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping unit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |