Duns Number:750551194
Device Description: N/A
Catalog Number
P1291522
Brand Name
Cochlear™ Slim Modiolar Electrode Sheath
Version/Model Number
P1291522
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"
Yes
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
-
Product Code
LRC
Product Code Name
INSTRUMENT, ENT MANUAL SURGICAL
Public Device Record Key
19d4425d-9fdc-42b4-96ea-059419db4b04
Public Version Date
February 24, 2022
Public Version Number
2
DI Record Publish Date
January 15, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 980 |