Duns Number:040729840
Device Description: STEINMANN PIN PACKAGE OF 6 SINGLE FULLY THREADED TROCAR TIP ROUND END
Catalog Number
1106-585
Brand Name
STEINMANN PIN PACKAGE
Version/Model Number
1106-585
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"
Yes
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
K100736
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
41f0122a-0fa6-4353-b632-db287fbac9bd
Public Version Date
June 25, 2019
Public Version Number
1
DI Record Publish Date
June 17, 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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |