Duns Number:094825235
Device Description: 4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 54
Catalog Number
22761-0021-2.7-54
Brand Name
SafetyFix Easy Out
Version/Model Number
4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 54
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
K180753
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
377ee292-7620-4c01-baeb-e2afd67e36d4
Public Version Date
September 24, 2019
Public Version Number
3
DI Record Publish Date
May 08, 2018
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. | 58 |