Duns Number:606417780
Device Description: 1.2 System 1.0mm Pilot Drill J-Latch Sterile Qty 2
Catalog Number
220-0001-SP-02
Brand Name
OsteoMed
Version/Model Number
220-0001-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
DZL
Product Code Name
SCREW, FIXATION, INTRAOSSEOUS
Public Device Record Key
14bf441b-413b-4ebc-a95e-128f415684d5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2017
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 |