Duns Number:315018218
Device Description: METHA µCAP 12/14 130°/0° SIZE 0 +5MM
Catalog Number
NC320T
Brand Name
Metha® MONO
Version/Model Number
NC320T
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
6c2781dd-74bb-46c2-ad05-662b6455a6bd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 26, 2015
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 |