Duns Number:071595540
Device Description: C-WIRE PAK DOUBLE ENDED ORTHOPAEDIC WIRE, TROCAR, .035 INCH (0.89MM), QTY 50
Catalog Number
00505004700
Brand Name
C-WIRE
Version/Model Number
00505004700
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
K142134,K142134,K142134
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
85bb8527-dd80-4183-b687-1537cd743b61
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 14, 2015
Package DI Number
20845854029111
Quantity per Package
50
Contains DI Package
10845854029114
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |