Duns Number:342243334
Device Description: Schanz Pin 5.0 mm dia. 190 mm long _x000D_Trokar point, 50 mm thread length _x0 Schanz Pin 5.0 mm dia. 190 mm long _x000D_Trokar point, 50 mm thread length _x000D_drawing KM72-220 REV#B (18.7.07)
Catalog Number
-
Brand Name
mahe medical GmbH
Version/Model Number
KM72-230
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
4148f5ac-4f7b-4e84-b7fb-a766a9ad719a
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
November 05, 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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1976 |