Duns Number:300764032
Device Description: Cochlear Implant
Catalog Number
39572
Brand Name
Mi1250 SYNCHRONY 2 PIN FLEX28 S-Vector Magnet
Version/Model Number
39544
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
P000025,P000025
Product Code
MCM
Product Code Name
Implant, Cochlear
Public Device Record Key
22b8aa63-97a0-40c1-9db5-26146e7f173e
Public Version Date
May 13, 2022
Public Version Number
3
DI Record Publish Date
December 15, 2020
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 |