Duns Number:187502109
Device Description: UNIVERSAL WEDGE 9MM X 25MM (1.5MM BORE)
Catalog Number
234-010-056
Brand Name
NA
Version/Model Number
234-010-056
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
K972233
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
3e008e82-269b-4c9e-95a6-839cb162c513
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 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 | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |