Duns Number:389566209
Device Description: Titanmagnetics® Insert K-Line D5.2/H3.75 for Nobel Replace Implant ø4.3 -> For further inf Titanmagnetics® Insert K-Line D5.2/H3.75 for Nobel Replace Implant ø4.3 -> For further information visit steco.de
Catalog Number
I.38.02.K375
Brand Name
StecoTitanmagnetics®
Version/Model Number
I.38.02.K375
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
EGG
Product Code Name
Attachment, Precision, All
Public Device Record Key
72f76158-67aa-4a8d-8148-5c0269f17a3e
Public Version Date
April 15, 2019
Public Version Number
2
DI Record Publish Date
August 20, 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 |