Duns Number:332893028
Device Description: Total middle ear implant, fixed size, titanium, round-centric head, 4.5x0.3 mm, sterile, 1 Total middle ear implant, fixed size, titanium, round-centric head, 4.5x0.3 mm, sterile, 1 piece
Catalog Number
11945
Brand Name
Total Middle Ear Implant
Version/Model Number
11945
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
ETA
Product Code Name
Replacement, Ossicular Prosthesis, Total
Public Device Record Key
2c616765-c668-4f07-a2ff-6dd445514071
Public Version Date
June 17, 2019
Public Version Number
1
DI Record Publish Date
June 07, 2019
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 |