Duns Number:835465063
Device Description: PROSTHESIS EN0002 CAUSSE FOOTPLT FLEX HA
Catalog Number
-
Brand Name
Causse
Version/Model Number
EN0002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2018
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
K810707
Product Code
ETA
Product Code Name
REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
Public Device Record Key
66f6c5d1-a39e-4a64-93b9-59a57934f88d
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
June 19, 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 | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |