Duns Number:481999654
Device Description: K-Wire, Single Trocar Point
Catalog Number
451-0031
Brand Name
AUTOFIX
Version/Model Number
451-0031
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
-
Product Code
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
83ed02f1-0b60-4457-b9b4-5d1e6785eb1d
Public Version Date
February 04, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
33700586902351
Quantity per Package
10
Contains DI Package
03700586902350
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2606 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9953 |
| 3 | A medical device with high risk that requires premarket approval | 186 |