Duns Number:332893028
Device Description: Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 1.75x0. Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 1.75x0.3 mm, sterile
Catalog Number
12917
Brand Name
Partial Middle Ear Implant
Version/Model Number
12917
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
K030492
Product Code
ETB
Product Code Name
Prosthesis, Partial Ossicular Replacement
Public Device Record Key
6fcfb74e-2280-4899-8442-fafc9dbdfa64
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 04, 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 | 1960 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 97 |