Catalog Number
-
Brand Name
QLRAD
Version/Model Number
105.1001
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180478,K180478
Product Code
PCT
Product Code Name
Prostate immobilizer rectal balloon
Public Device Record Key
78e838cc-5418-4642-bf76-689016c8ea96
Public Version Date
September 22, 2021
Public Version Number
1
DI Record Publish Date
September 14, 2021
Package DI Number
08719326258270
Quantity per Package
100
Contains DI Package
08719326258256
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box