Duns Number:842448610
Device Description: Prostate Immobilization device. Rectal Balloon with inflation syringe, single use, non-st Prostate Immobilization device. Rectal Balloon with inflation syringe, single use, non-sterile. Box of 25.
Catalog Number
9901
Brand Name
Prostate Caddy Rectal Balloon
Version/Model Number
9901
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"
Yes
For Single-Use
Yes
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
-
Product Code
PCT
Product Code Name
Prostate Immobilizer Rectal Balloon
Public Device Record Key
bbc7bf0d-32df-49d0-9350-160de74fda84
Public Version Date
October 01, 2020
Public Version Number
1
DI Record Publish Date
September 23, 2020
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |