Duns Number:808875397
Device Description: VacQfix Cushion, 100cm x 130cm, PEN, 45L fill
Catalog Number
RT-4517-100130PENF45M
Brand Name
VacQfix™
Version/Model Number
RT-4517-100130PENF45M
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
K060671
Product Code
JAI
Product Code Name
Couch, radiation therapy, powered
Public Device Record Key
2f1519fd-3b06-47de-911e-f8949aeb847d
Public Version Date
February 11, 2022
Public Version Number
1
DI Record Publish Date
February 03, 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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 998 |