Duns Number:103977526
Device Description: Reusable non-sterile Combifix™ baseplate with (2) elevation blocks, Feetfix™ bracket, Feet Reusable non-sterile Combifix™ baseplate with (2) elevation blocks, Feetfix™ bracket, Feetfix™ cushion, and low Kneefix™ cushion
Catalog Number
151003
Brand Name
Combifix™
Version/Model Number
151003
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 20, 2020
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
K060737
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
3926611f-85aa-494c-90a8-8b0d6a3f2afc
Public Version Date
January 20, 2020
Public Version Number
7
DI Record Publish Date
August 02, 2017
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1027 |