Duns Number:389566209
Device Description: Titanmagnetics® torque wrench insert X-Line for Epitec-ratchet-> For further information v Titanmagnetics® torque wrench insert X-Line for Epitec-ratchet-> For further information visit steco.de
Catalog Number
H.11.01.X1
Brand Name
StecoTitanmagnetics®
Version/Model Number
H.11.01.X1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
For Single-Use
-
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
5ac123f6-fff0-4e15-8162-abbdd3e30ce4
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 |