Duns Number:438793622
Device Description: FFS LARGE IMPLANTS L 120/40 MM STERILE THREAD D 2.2 MM (PACK OF 4)
Catalog Number
99-W2240
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
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
K944092
Product Code
JEC
Product Code Name
Component, Traction, Invasive
Public Device Record Key
0dae808b-a764-4a29-9a44-20ebe7641dc1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 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 | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6371 |