Duns Number:086618626
Device Description: STEIN.PIN D.DMD.THR.9" 5/32"4.0MM
Catalog Number
OM 71-0745R
Brand Name
ORTHOMED
Version/Model Number
OM 71-0745R
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
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
ac0ee292-1152-495f-b3b8-dd90e1b2f6e4
Public Version Date
June 17, 2020
Public Version Number
1
DI Record Publish Date
June 09, 2020
Package DI Number
B8037107453
Quantity per Package
6
Contains DI Package
B803710745R0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
TUBE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 938 |
2 | A medical device with a moderate to high risk that requires special controls. | 155 |