Duns Number:389566209
Device Description: Titanmagnetics® epitheses magnet X-Line D4.8/H2.65 universal with retention ring for silic Titanmagnetics® epitheses magnet X-Line D4.8/H2.65 universal with retention ring for silicone -> For further information visit steco.de
Catalog Number
U.00.02.X265
Brand Name
StecoTitanmagnetics®
Version/Model Number
U.00.02.X265
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
KCZ
Product Code Name
Prosthesis, Breast, External, Used With Adhesive
Public Device Record Key
d690ac15-0411-4085-ba2f-4e3f0982a1fa
Public Version Date
April 15, 2019
Public Version Number
3
DI Record Publish Date
February 12, 2018
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 | 31 |