Duns Number:312844095
Device Description: The Cranio-caudal Fixation Unit CC-GE is a medical product and it is indicated for the cra The Cranio-caudal Fixation Unit CC-GE is a medical product and it is indicated for the cranio-caudal immobilization of the female breast. The application must only be performed by trained medical personal.
Catalog Number
118231
Brand Name
Cranio-caudal fixation unit CC-GE
Version/Model Number
01
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
K052987
Product Code
MOS
Product Code Name
Coil, Magnetic Resonance, Specialty
Public Device Record Key
8c9e5ed7-7676-4781-94be-881f8266d16a
Public Version Date
July 14, 2022
Public Version Number
1
DI Record Publish Date
July 06, 2022
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 518 |