Duns Number:206950904
Device Description: Freedom 6 Couch Extension Head & Neck
Catalog Number
SB02
Brand Name
Freedom
Version/Model Number
1
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
K122888,K122888
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
161c86fa-d8a8-492d-bc12-def071d2b415
Public Version Date
January 08, 2020
Public Version Number
1
DI Record Publish Date
December 31, 2019
Package DI Number
10628341930175
Quantity per Package
1
Contains DI Package
00628341930178
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 23 |