Duns Number:078642955
Device Description: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 RECESS / 10.0 MM
Catalog Number
202.870.EM
Brand Name
EMERGE MEDICAL & Design
Version/Model Number
202.870.EM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2018
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
4644b703-50cc-42c3-8b51-b75196074fed
Public Version Date
May 01, 2018
Public Version Number
4
DI Record Publish Date
July 07, 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 | 288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1273 |