Duns Number:606417780
Device Description: 1.6mm, Left Zed Plate, 11mm
Catalog Number
213-0127
Brand Name
OsteoMed
Version/Model Number
213-0127
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
DZL
Product Code Name
SCREW, FIXATION, INTRAOSSEOUS
Public Device Record Key
80fde2f8-610b-4036-82e0-6be6f224243e
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
April 08, 2015
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 | 95 |
2 | A medical device with a moderate to high risk that requires special controls. | 7762 |
U | Unclassified | 105 |