Duns Number:071595540
Device Description: 1.5MM BONE FIXATION KIT, DIAMETER 1.5 X 25MM, QTY 2
Catalog Number
BXS6225
Brand Name
NA
Version/Model Number
BXS6225
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
-
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
12bb0f5e-aca0-4167-9610-68ed741d180b
Public Version Date
August 02, 2018
Public Version Number
1
DI Record Publish Date
July 02, 2018
Package DI Number
30845854017153
Quantity per Package
2
Contains DI Package
10845854017159
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 |