Duns Number:989365556
Device Description: DEPUY CMW 3 Medium Viscosity Bone Cement 40g
Catalog Number
3332040
Brand Name
NA
Version/Model Number
3332-040
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053003,P960001,P960001,K053003,P960001,P960001,K053003,P960001,P960001
Product Code
LOD
Product Code Name
BONE CEMENT
Public Device Record Key
994e56a2-af65-4460-b0ff-a065fdc92e37
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2015
Package DI Number
30603295168632
Quantity per Package
20
Contains DI Package
10603295168638
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3549 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2188 |
| 3 | A medical device with high risk that requires premarket approval | 418 |