Duns Number:438793622
Device Description: Spare part, not medical device, not for sale. Reported for registration of UDI direct mark Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
Catalog Number
W10017
Brand Name
FRAGMENT FIXATION SYSTEM
Version/Model Number
1
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
-
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
K944092
Product Code
JEC
Product Code Name
Component, Traction, Invasive
Public Device Record Key
9f0db76c-c303-4d5e-8014-2fa8fce3481f
Public Version Date
September 16, 2022
Public Version Number
6
DI Record Publish Date
April 19, 2019
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 | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6371 |