Duns Number:206950904
Device Description: Freedom Prone Head & Neck Immobilization (MR Conditional)
Catalog Number
PH08-K
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
MR Conditional
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
7a9b64e8-fb63-4ef4-8c49-1b737215f7c1
Public Version Date
May 25, 2020
Public Version Number
1
DI Record Publish Date
May 15, 2020
Package DI Number
10628341930427
Quantity per Package
1
Contains DI Package
00628341930420
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 |