Duns Number:109903521
Device Description: JET-X CNTRL BODY TO CNTRL BODY HINGED CONNECTOR
Catalog Number
71051056
Brand Name
Jet-X Central
Version/Model Number
71051056
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 17, 2022
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K994143
Product Code
JDW
Product Code Name
PIN, FIXATION, THREADED
Public Device Record Key
0544a624-708c-4e74-9fc0-83a774d68f0a
Public Version Date
March 18, 2022
Public Version Number
6
DI Record Publish Date
August 25, 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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |