Duns Number:606417780
Device Description: 2.7mm x 18mm Variable Angle Locking Screw, Sterile, Qty 2
Catalog Number
359-2718-SP-02
Brand Name
OsteoMed
Version/Model Number
359-2718-SP-02
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
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
8c081162-b7f7-46cc-8426-96ecc25816c2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 14, 2016
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 |