Duns Number:315731430
Device Description: FISCH Titanium Total Prosthesis with Foot, 0.6 x 10 mm
Catalog Number
227520
Brand Name
N/A
Version/Model Number
227520
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
K043375
Product Code
ETA
Product Code Name
Replacement, Ossicular Prosthesis, Total
Public Device Record Key
91ff7993-b5fe-4c74-9c8c-44fc24956a4e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 09, 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 | 3584 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4864 |
| 3 | A medical device with high risk that requires premarket approval | 18 |