Duns Number:315018218
Device Description: PLASMACUP MSC SIZE 66MM
Catalog Number
NH166T
Brand Name
Plasmacup®
Version/Model Number
NH166T
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
-
Product Code
LWJ
Product Code Name
Prosthesis, hip, semi-constrained, metal/polymer, uncemented
Public Device Record Key
78a71b09-d7f5-4eff-9a8b-71f45f95ffda
Public Version Date
September 09, 2020
Public Version Number
3
DI Record Publish Date
February 26, 2017
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 | 11840 |
2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
3 | A medical device with high risk that requires premarket approval | 37 |