Duns Number:485262658
Device Description: Resin Black
Catalog Number
-
Brand Name
Slim HP Color Cap
Version/Model Number
CI-7131-011
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P960058,P960058
Product Code
MCM
Product Code Name
Implant, Cochlear
Public Device Record Key
2de8df0a-2899-4e05-ae7c-4ff1ecdf5251
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
February 11, 2021
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 |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 842 |