Duns Number:007198742
Device Description: Replace the portion of the ossicular chain that has lost its function due to disease conge Replace the portion of the ossicular chain that has lost its function due to disease congenital defect or other pathological process
Catalog Number
-
Brand Name
RICHARDS PISTON 45 MM LENGTH 6MM DIAMETER PLATINUM FLUOROPLASTIC
Version/Model Number
140785
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K760435
Product Code
ETB
Product Code Name
Prosthesis, Partial Ossicular Replacement
Public Device Record Key
6ef69b95-6bf6-4b5e-846c-74256b595740
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |