Duns Number:109903521
Device Description: STEINMAN PIN TROCAR PT ROUND END 7/64 X 9
Catalog Number
128099
Brand Name
OTHER EXTERNAL FIXATION
Version/Model Number
128099
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)
Yes
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
4e760044-9e51-401b-a3b2-f8af487dd47f
Public Version Date
November 23, 2021
Public Version Number
3
DI Record Publish Date
August 29, 2015
Package DI Number
23596010082880
Quantity per Package
6
Contains DI Package
03596010082886
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |