Duns Number:070061160
Device Description: 3MM SELF TAPPING HALF PIN, 15MM THREAD LENGTH, 110MM LONG
Catalog Number
-
Brand Name
OIC External Fixation System
Version/Model Number
STHP-0315M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 26, 2021
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
KTT
Product Code Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Public Device Record Key
612848be-f015-4080-97dc-173541b2d137
Public Version Date
September 29, 2021
Public Version Number
2
DI Record Publish Date
May 26, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1585 |