Duns Number:947090650
Device Description: Othropedic Fracture Attachment system used to pull traction and articulate the legs of pat Othropedic Fracture Attachment system used to pull traction and articulate the legs of patient for various procedures.
Catalog Number
OZ 7531704
Brand Name
Euro Orthopedic Fracture Attachment
Version/Model Number
3-2006-001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWN
Product Code Name
Table And Attachments, Operating-Room
Public Device Record Key
a3d4ca1c-b125-497a-a326-d531b620898e
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 24, 2020
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |