Duns Number:030849173
Device Description: CENTERED ALTO PARTIAL 10MM LENGTH TITANIUM/SILICONE
Catalog Number
-
Brand Name
CENTERED ALTO PARTIAL 10MM L
Version/Model Number
655-M2
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
K061853
Product Code
ETB
Product Code Name
Prosthesis, Partial Ossicular Replacement
Public Device Record Key
966e07ae-e08e-4fa9-944c-6caff195db88
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 16, 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 | 200 |
2 | A medical device with a moderate to high risk that requires special controls. | 564 |