Duns Number:300764032
Device Description: Middle Ear Implant
Catalog Number
-
Brand Name
Vibrating Ossicular Prosthesis (VORP 502A, right)
Version/Model Number
11332-001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
P990052,P990052,P990052,P990052,P990052,P990052,P990052,P990052,P990052,P990052
Product Code
MPV
Product Code Name
Implant, Hearing, Active, Middle Ear, Partially Implanted
Public Device Record Key
4785b4c9-a69b-4f33-ae2e-e4665f0fd343
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2014
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 70 |
| 3 | A medical device with high risk that requires premarket approval | 773 |