Duns Number:947090650
Device Description: Orthopedic fracture attachment system used to pull traction and articulate the legs of pat Orthopedic fracture attachment system used to pull traction and articulate the legs of patient for various procedures.
Catalog Number
OZ 7531775
Brand Name
Orthopedic Fracture Attachment Kit, Berchtold
Version/Model Number
3-1000-001
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
0ba62f8e-790e-4bc7-8df8-d13416244818
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 14, 2021
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 |